ISOMEDIX OPERATIONS INC

FDA Device Registration & Listing · EL PASO, TX, US · Registration 1643817

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1643817
FEI Number
1643817
Entity Name
ISOMEDIX OPERATIONS INC
City/State/Country
EL PASO, TX, US
Establishment Address
1435 ISOMEDIX PLACE, EL PASO, TX 79936, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 1527821)
Owner / Operator Contact Address
5960 Heisley Rd, --, Mentor, OH 44060, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BVI1689 (EP1) - Guibor Canaliculus Intubation Set (CIS) BVI1689 (EP1) - Canaliculus Intubation Set (CIS) 15.5 Cm Long Ortho1399 (SN,EP1) - Balanced Knee System Ultracongruent Tibial Insert US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (3 pc kit) US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (4 pc kit) OcoBiomed2873 (EP1) - TSI / ERI OcoBiomed2873 (EP1) - Engage / Engage Plus NovoSci7187 (EP1) - Heat-exchanger Cardipulmonary bypass NovoSci7187 (EP1) - Filter, blood, cardiopulmonary bypass, arterial line Ortho1399 (SN,EP1) - Balanced Knee Modular Tibial System NovoSci7187 (EP1) - Accessory Equipment, Cardiopulmonary Bypass Avanos2508 (EP1,EP2) - MIC-KEY* Avanos2508 (EP1,EP2) - MIC* Ortho1399 (SN,EP1) - Balanced Knee System Modular Revision Knee System NovoSci7187 (EP1) - Accessory Equipment, Cardiopulmonary Bypass Zimmer (LN) - PRECISION FLX RMR 5MM DISP Zimmer (LN)- PRECISION FLX RMR 5.5MM DISP Zimmer (LN) - precision flexible reamer disposable 9.5mm Zimmer (LN) - precision flexible reamer disposable 12mm Zimmer (LN) - precision flexible reamer disposable 4.5mm Zimmer (LN) - precision flexible reamer disposable 11mm Zimmer (LN) - precision flexible reamer disposable 7.5mm Zimmer (LN) - precision flexible reamer disposable 8mm Zimmer (LN)- PRECISION FLX RMR 6MM DISP Zimmer (LN) - precision flexible reamer disposable 9mm Zimmer (LN) - precision flexible reamer disposable 11.5mm Zimmer (LN) - precision flexible reamer disposable 7mm Zimmer (LN) - precision flexible reamer disposable 10.5mm Zimmer (LN) - PRECISION FLX RMR 6.5MM DISP Zimmer (LN) - precision flexible reamer disposable 8.5mm Zimmer (LN, LS) - Trauma Fixation Systems Zimmer (LN) - precision flexible reamer disposable 10mm Viant8257 (NR,WH*) - Reamer Avanos2508 (EP1) - Radiofrequency Probe-Curved Avanos2508 (EP1,EP2,NT) - MIC PEG TUBE Avanos2508 (EP1,EP2,NT) - MIC PEG Kit Ortho1399 (SN,LN*) - Ortho Development Balanced Knee System BVI1689 (EP1) - Visitec Visimark Marking Pad Ortho1399 (SN,EP1) - Headloc Ceramic Femoral Head Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System BVI1689 (EP1) - Extend™ Synthetic Implants (0.2mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (0.5mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (0.3mm X 2mm) BVI1689 (EP1) - Extend™ Synthetic Implants (Variety Pack) BVI1689 (EP1) - Extend™ Synthetic Implants (0.4mm X 2mm Ortho1399 (SN,EP1) - Escalade Acetabular Cup System Avanos2508 (EP1,EP2) - Kimberly-Clark Avanos2508 (EP1,EP2) - Endoscopic Accessories Avanos2508 (EP1,EP2) - Cytology Brush BVI1689 (EP1) - Beaver Mini-Blades CircumFix11320 (EP1) - VariTrax Sternal Circumfixator Plate 166mm CircumFix11320 (EP1) - Varitrax Sternal Circumfixator Set,  130mm CircumFix11320 (EP1) - Varitrax Sternal Circumfixator Set,  166mm CircumFix11320 (EP1) - Varitrax Sternal Circumfixator Set,  186mm CircumFix11320 (EP1) - VariTrax Sternal Templating Kit CircumFix11320 (EP1) - VariTrax Sternal Circumfixator Plate 186mm CircumFix11320 (EP1) - Varitrax Sternal Circumfixator Set,  142mm CircumFix11320 (EP1) - VariTrax Sternal Circumfixator Plate 130mm CircumFix11320 (EP1) - Varitrax Sternal Circumfixator Set,  178mm CircumFix11320 (EP1) - Varitrax Sternal Circumfixator Set,  154mm CircumFix11320 (EP1) - VariTrax Sternal Circumfixator Plate 142mm CircumFix11320 (EP1) - VSC Locking Band with Curved Blunt Needle CircumFix11320 (EP1) - VariTrax Sternal Circumfixator Plate 154mm CircumFix11320 (EP1) - VariTrax Sternal Circumfixator Plate 178mm Avanos2508 (NT) - Neonatal Percussor BVI1689 (EP1) - Ophthalmic Burr Avanos2508 (EP1,EP2) - CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE Ortho1399 (SN,EP1) - Press-fit Hip System: Encompass Hip Stem Ortho1399 (SN,EP1) - Tri-plus Acetabular Shell Ortho1399 (SN,EP1) - Encompass Plasma Sprayed Ortho1399 (SN,EP1) - Tri-plus DCM Liner Medivators2752 (EP1) - CLEANASCOPE Linerset Olympus2295 (MN) - Cleaning Accessories StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 6.5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS, VG) - CANNULA PLUG StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 6.5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 90mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 90mm Threaded Cannula StrykerPR3324 (GR, LS) - 5mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 8 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5 X 75mm Dri-Lok Cannula Threaded StrykerPR3324 (GR, LS) - 8mm X 75mm Distal Threaded Cannula StrykerPR3324 (GR, LS) - 6.5 X 75mm Dri-Lok Cannula Non-Threaded StrykerPR3324 (GR, LS) - 5mm X 90mm Threaded Cannula Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 45mm Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, with Distal Rib Smith&Nephew3754 (NR) - Fixation Post, 5mm x 30mm Smith&Nephew3754 (NR) - DISP KNIFE ROSSETTE 3MM STR(5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Threaded Smith&Nephew3754 (NR) - SUTURE Threaders Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - ACUFEX Clear.Trac Threadedd.10 IDx76 LTX(10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE V SHAPED Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 35mm Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 8mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Threaded Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 90mm, Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE HOOK 3MM (5) Smith&Nephew3754 (NR) - Split Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 4.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - CLEAR-TRAC Disposable Scope/Shaver Cannula, Smooth Smith&Nephew3754 (NR) - TRANSPORTER (BOX 4) STERILE Smith&Nephew3754 (NR) - Clear-Trac Thrd Cann 5mm/76mm LTX Free (10) B Smith&Nephew3754 (NR) - Endoscopic Cann.Drill.Bit 4.5mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 90mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 40mm Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 6.5 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 7mm x 72mm, Smooth Smith&Nephew3754 (NR) - Univ Cannula 5mm/76mm LTX Free (10) Blue Smith&Nephew3754 (NR) - 3.8mm Tapered Awl, Disposable Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 9mm LTX Free (10) Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SERRATED (5) Smith&Nephew3754 (NR) - PCL Safety Guidewire, 2.4mm x 25cm Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 12” (Box 5) Smith&Nephew3754 (NR) - Guide Wire, 1.2mm x 9” (Box 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 4.5 x 72mm Threaded Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 30mm Smith&Nephew3754 (NR) - MENISCUS MENDER II DISPOSABLE Smith&Nephew3754 (NR) - Clear-Trac Complete Hip Cannula Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 45mm, Threaded Smith&Nephew3754 (NR) - Clear-Trac Screw Cann 7mm LTX Free (10) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Threaded Smith&Nephew3754 (NR) - DISPOSABLE KNIFE SHARP TIP Smith&Nephew3754 (NR) - Flexible Passing Pin, 13.50” X 2.4mm (Qty 5) Smith&Nephew3754 (NR) - SUTURE PASSER 2 STERILE Smith&Nephew3754 (NR) - Passing Pin, Drill Tip, 2.4mm x 15” Smith&Nephew3754 (NR) - DISP KNIFE SERRATED FLAT(BX 5) Smith&Nephew3754 (NR) - Clear-Trac Threaded Cann 8mm/76mm LTX Free (10) G Smith&Nephew3754 (NR) - (6) Guidewire 2mm x 15 Smith&Nephew3754 (NR) - Univ Cannula 7mm/76mm LTX Free (10) Green Smith&Nephew3754 (NR) - (5) Guidewire, 1.2mmx 18” (46 cm) Smith&Nephew3754 (NR) - Fixation Post, 5mm x 35mm Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 25mm Smith&Nephew3754 (NR) - SUTURE PASSER 12 STERILE Smith&Nephew3754 (NR) BONE TUNNEL PLUG CANN 7-12MM LTX FREE (6 Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 8 x 72mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 8.5mm x 72mm, Threaded Smith&Nephew3754 (NR) - Fixation Post, 5mm x 25mm Smith&Nephew3754 (NR) - Clear-Trac Complete Stopcock Valve Smith&Nephew3754 (NR) - Fixation Post, 6.5mm x 40mm Smith&Nephew3754 (NR) - DISP KNIFE ROUND TIP (BX 5) Smith&Nephew3754 (NR) - CLEAR-TRAC Flexible Cannula, 5.5 x 55mm Smooth Smith&Nephew3754 (NR) - Clear-Trac Complete Cannula System, 5.5mm x 72mm, Threaded Conmed (SX) - FENESTRATED CANNULA OcoBiomed2873 (EP1) - Immediate Stabilizing Implant (ISI) BVI1689 (EP1) - Visitec Aspirating syringe Ortho1399 (SN,EP1) - ODC B2 Bipolar Cup Hollister (SP,LS,LN) - Moderma Flex; New Image; Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkin Hollister (LN, LS) - Ostomy Skin Barriers Hollister (SP,LS,LN) - Premier; Restore; Securi-T USA; Suavita; Tandem; Urostomy Drain Tube Adapter Hollister (LN, LS) - Hollister Hollister (SP,LS,LN) - Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Colle Hollister (SP,LS,LN) -First Choice; Holligard; Hollister Solo Stoma Cap; Invent; Karaya 5; Moderma Flex; New Image Aspen1609 (EP1,MN) - Neddle Guides, General Purpose Aspen1609 (EP1,MN) - Transrectal Needle Guide Ortho1399 (SN,EP1) - Balanced Knee Tibial Tray Pegged Avanos2508 (EP1,EP2) - Syringe Ortho1399 (SN,EP1) - Ceramic Femoral Heads With Press-fit Stems Ortho1399 (SN,EP1) - 10x17 and 12x17 Extended Stems Ortho1399 (SN,EP1) - Encompass Press-fit Hip Stem Aspen1609 (EP1,MN) - Probe Cover, Endocavity Ortho1399 (SN,EP1) - Primaloc Cemented Hip System BVI1689 (EP1) - Wet-Field Eraser, 23GA Blunt Tip 90 Degree BVI1689 (EP1) - Wet-Field Eraser 20-23 GA Tapered Blunt Tip Straight BVI1689 (EP1) - Wet-Field Eraser 25 GA Fine Tip 135 Degree BVI1689 (EP1) - Wet-Field Eraser 23 GA Fine Tip 150 Degree BVI1689 (EP1) - Wet-Field Eraser 25 GA Fine Tip 150 Degree BVI1689 (EP1) - Wet-Field Eraser, 18GA Blunt Tip 45 Degree BVI1689 (EP1) - Wet-Field Eraser 23 GA Fine Tip 135 Degree BVI1689 (EP1) - Wet-Field Eraser 25 GA Fine Tip Straight BVI1689 (EP1) - Wet-Field Eraser, 23GA Blunt Tip Straight BVI1689 (EP1) - Wet-Field Osher ThermoDot Marker 25GA fine tip BVI1689 (EP1) - Wet-Field Eraser, 20GA Blunt Tip Straight BVI1689 (EP1) - Wet-Field Eraser 23 GA Fine Tip Straight BVI1689 (EP1) - Wet-Field Eraser, 20GA Blunt Tip 150 Degree BVI1689 (EP1) - Wet-Field Eraser 20-23 GA Tapered Fine Tip Straight BVI1689 (EP1) - Wet-Field Eraser, 20GA Blunt Tip 135 Degree BVI1689 (EP1) - Wet-Field Eraser 18 GA Blunt Tip 45 Degree BVI1689 (EP1) - Wet-Field Eraser 18 GA Bevel Tip BVI1689 (EP1) - Wet-Field Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System Ortho1399 (SN,EP1) - Entrada Hip Stem Carefusion (EP1,SN,LS,NT) - PrimeSaver Sets (Ball Valve) Merit1383 (SN) - ShortStop Temporary Sharps Holder Merit1383 (TM) - BackStop Plus Closed Waste Basin Merit1383 (SN) - ShortStop Advantage Temporary Sharps Holder Merit1383 (NT,SN) - ShortStop Advantage Temporary Sharps Holder Ranfac3098 (NR) - SS-1529, Hypodermic Needle, S-115 BVI1689 (CH1,EP1) - Retrobulbar BVI1689 (EP1, CH1) - Peribulbar Clearside6394 (MN,SP) - SCS Microinjector Depuy (NR) - CELLECT BONE MARRO; CONFIDENCE SPINAL CEMENT SYSTEM Ortho1399 (SN,EP1) - Primaloc Cementless Hip System BVI1689 (EP1, CH1) - Plus Pre-Loaded Punctal Occluder Ranfac3098 (NR) - Ranfac Injection Needle Ortho1399 (SN,EP1) - Contour Spinal System Ortho1399 (SN,EP1) - Pagoda Pedicle Screw System; Pagoda® Pedicle Screw NovoSci7187 (EP1) - Oxygenator, Cardiopulmonary bypass Aspen1609 (EP1,MN) - Probe Cover Ethicon (EP1) - Instrument, Ultrasonic Surgical PFMMedical6614 (TM) - Jet-Vac Drainage Line (Ref M7099) PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref M7004) PFMMedical6614 (TM) - Jet-Vac Large Bore Drainage Line Set (Ref M7098) PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref M7005) PFMMedical6614 (TM) - Jet-Vac Drainage Line Extension (Ref M7097) PFMMedical6614 (TM) - ASEPT Power Flush Adaptor Ursel11054 (MN) - Posi-Stick Introducer Set Prava (LSRTC) - UGARing Merit1383 (TM) - Prelude SNAP 165 Valved Splittable Sheath Introducer NovoSci7187 (EP1) - Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass Protech3048 (TM) - Falcon Protech3048 (TM) - Awl Protech3048 (TM) - Lightning ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy OFP & EndoStat Pump Tubing/Cap Set ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Back Flow Valve ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Port Connector for Pentax Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Pump Tubing/Cap Set ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Port Connector w/Valve for Olympus Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Channel Adapter ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Port Connector for Olympus Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO® 2 Endoscopy Pump Tubing/Cap Set for Fujinon Scopes NovoSci7187 (EP1) - Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass Avanos2508 (EP1,EP2) - Single Shot Epidural Trays Avanos2508 (EP1,EP2) - Epidural Tray Avanos2508 (EP1,EP2) - Universal Block Tray Avanos2508 (EP1,EP2) - Spinal Tray Avanos2508 (EP1,EP2) - Myelogram Trays Avanos2508 (EP1,EP2) - Epi-Spinal Trays Avanos2508 (EP1,EP2) - Nerve Block Tray Avanos2508 (EP1,EP2) - PMP Kits and Catheters Atrium1623 (NR) - Chest Drain Accessories Ursel11054 (MN) - Thora-Vent Thoracic Vent PFMMedical6614 (TM) - Asept; Jet-Vac Avanos2508 (EP1,EP2,NT) -MIC-KEY G Avanos2508 (EP1,EP2,NT) - MIC and MIC-KEY G-Tube and Extension Sets Ortho1399 (SN,EP1) - Vusion PEEK VBR System BVI1689 (EP1) - Spear Tip Myringotomy Knife - 45 Degree BVI1689 (EP1) - Myringotomy Knife Lance Tip - 45 Degree BVI1689 (EP1) - BVI Blu-Spot Diagnostic Penlight BVI1689 (EP1) - Maxi-Lite BVI11689 (EP1) - Visitec® Single Fluid Administration Set BVI11689 (EP1) - Visitec® Double Male Luer Nurse11268 (GR) - USP Sterile Water, 500mL, Screw Top Bottle Nurse11268 (GR) - USP Normal Saline, 500mL, Screw Top Bottle Nurse11268 (GR) - USP Normal Saline, 250mL Screw Top Bottle Ortho1399 (SN,EP1) - Pivot Bipolar Head Avanos2508 (EP1) - Radiofrequency Probe Kit-Straight Avanos2508 (EP1) - Radiofrequency Probe Avanos2508 (EP1) - Radiofrequency Probe Kit-Curved Avanos2508 (EP1) - Radiofrequency Generator Connector Cable Avanos2508 (EP1) - Radiofrequency Bipolar Adapter Avanos2508 (EP1,EP2) - Single Shot Tray Products or Continuous Tray Products Carefusion (NT,LS) - set, administration, intravascular; set, I.V., fluid transfer Carefusion5709 (TM) - Alaris Medical Infusion System Administration Sets- NovoSci7187 (EP1) - Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass NovoSci7187 (EP1) - Catheter, cannula and tubing, vascular, cardiopulmonary bypass Teleflex (EP2) - PICC Carefusion (EP1,SN,LS,NT) - Alaris Safety Male Luer Puritan5503 (NR) - Puritan, DM Stick Sterile Foam Tipped Measuring Device Solventum14471 (SP) - 3M™ Steri-Drape™ Ethicon (EP1) - Instrument, Ultrasonic Surgical BVI1689 (EP1,CH1) - Parasol® Pre-Loaded Punctal Occluder X-Small 0.25mm – 0.35mm BVI1689 (EP1,CH1) - Parasol® Pre-Loaded Punctal Occluder Small 0.35mm – 0.65mm BVI1689 (EP1,CH1) - Parasol® Quickload™ Punctal Occluder Small 0.35mm – 0.65mm BVI1689 (EP1,CH1) - Parasol® Pre-Loaded Punctal Occluder Medium 0.6mm – 0.85mm BVI1689 (EP1,CH1) - Parasol® Quickload™ Punctal Occluder Medium 0.6mm – 0.85mm BVI1689 (EP1,CH1) - Parasol® Quickload™ Punctal Occluder Large 0.9mm+ BVI1689 (EP1,CH1) - Parasol® Pre-Loaded Punctal Occluder Large 0.9mm+ BVI1689 (EP1,CH1) - Parasol® Quickload™ Punctal Occluder Combo Pack Small Medium Neilmed6807 (NT) - NeilMed Clear Canal Earwax Complete Removal Kit - All Natural ICU7944 (SP,EP1) - EMPTY CONTAINER 1000mL ICU7944 (SP,EP1) - EMPTY CONTAINER 250mL ICU7944 (SP,EP1) - EMPTY CONTAINER ICU7944 (SP,EP1) - EMPTY CONTAINER 100mL Merit1383 (SN,NT) - Futura Safety Scalpel BVI1689 (EP1) - Beaver Sclerotome Blade BVI1689 (EP1) - Beaver Mini-Blades BVI1689 (EP1) - Beaver Pocket Blade BVI1689 (EP1) - BeaverGuard Blade S&N3754 (NR) - WHIPKNOT #5 Soft Tissue Cinch StrykerPR3324 (LN) - Femoral Canal Brush NovoSci7187 (EP1) - adaptor, stopcock, manifold, fitting, cardiopulmonary bypass PFMMedical6614 (TM) - VETA Peritoneal Dialysis Introducer Kit (Ref M7230) Carefusion (EP1) - Gemini/Alaris Pump Module sets Carefusion5709 (EP1) - Alaris Pump Module SmartSite Low Sorbing Infusion Set Carefusion (NT) - set, administration, intravascular OcoBiomed2873 (EP1) - 3 Dental Implant Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC NERVE BLOCK WITH NRFit" CONNECTOR Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Ultrasound Nerve Block Prep Tray Avanos2508 (EP1,EP2) - anesthesia conduction kit - ON-Q* Pain Relief System T-Bloc Continuous Echogenic Nerve Block Tray Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Needle/Catheter Set Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC STIMULATING NERVE BLOCK TRAY WITH NRFit" Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* ECHOGENIC STIMULATING NEEDLE/CATHETER SET WITH NRFit" CONNECTOR Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Continuous Echogenic Stimulating Nerve Block Tray Avanos2508 (EP1,EP2) - ON-Q* PAIN RELIEF SYSTEM T-BLOC* ULTRASOUND NERVE BLOCK PREP TRAY WITH NRFit" CONNECTOR Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Echogenic Needle/Catheter Set Avanos2508 (EP1,EP2) - PERIPHERAL NERVE BLOCK SUPPORT TRAY Avanos2508 (EP1,EP2) - ON-Q* Pain Relief System T-Bloc* Echogenic Stimulating Needle/Catheter Set ErbeUSA9143 (SP, EP1) - ERBEFLO® Olympus® Scope Port Connector Ortho1399 (SN,EP1) - Balanced Knee System Revision Offset Tibia Merit1383 (TM) - K04 - Tubing Kit Merit1383 (TM) - K08- Fluid Management Kit NovoSci7187 (EP1) - Clamp, Vascular Ortho1399 (SN, EP1*) - Ibis Pedicle Screw System Avanos2508 (EP1) - LumbarCool Avanos2508 (EP1) - Sinergy Avanos2508 (EP1) - Transdiscal Avanos2508 (EP1) - ThoraCool Ranfac3098 (NR) - ORC-B, ORC-A, LAP-13, ORC-XL11 Ranfac3098 (NR) - Cholangiography Catheter Avanos2508 (EP1,EP2,NT) - MIC LOW PROFILE GASTROSTOMY TUBE Avanos2508 (EP1,EP2,NT) - CORFLO* PEG Kit Ortho1399 (SN,EP1) - Legend All-poly Cup ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Olympus® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid OFP & EndoStat Tubing/Cap Set for Olympus® Scope ErbeUSA9143 (SP,EP1) - ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Olympus® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Fujinon® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Fujifilm® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO AeroRinse® Air and Water Tubing/Cap Set for Pentax® Scopes ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid Tubing/Cap Set for Pentax® Scopes NovoSci7187 (EP1) - Catheter, cannula and tubing, vascular, cardiopulmonary bypass Jabil3944 (EP1) - MANIFOLD KIT, US, DEHP FREE, STERILIZED Jabil3944 (EP1) - MANIFOLD KIT, US,Sterilized, Steris Jabil3944 (EP1) - MU, SYRINGE KIT, US, DEHP FREE, STERILIZED Jabil3944 (EP1) - SYRINGE KIT, US,Sterilized, Steris Merit1383 (TM) - ReSolve Locking Drainage Catheter AmericanCatheter5917 (SP) - American Catheter Merit1383 (TM) - Cen-Step Centesis Catheter ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Fujinon® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Pentax® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & CO2 Sources ErbeUSA9143 (SP, EP1) - ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Pentax® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Fujinon® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Olympus® Scopes ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Olympus® Scopes & UCR ErbeUSA9143 (SP, EP1) - ERBEFLO AeroRinse® CO2 and Water Tubing/Cap Set for Olympus® Scopes & UCR ErbeUSA9143 (SP, EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Fujifilm® Scopes Conmed (EP1) - SMOKE EVALUATION Insufflator, Laparoscopic BVI1689 (EP1,CH1) - Collagen Temporary Implants 0.3mm x 2mm BVI1689 (EP1,CH1) - Collagen Temporary Implants 0.2mm x 2mm BVI1689 (EP1) - Collagen Implants Variety Pack BVI1689 (EP1) - Collagen Temporary Implants 0.4mm x 2mm Ortho1399 (SN,EP1) - Escalade Legend Acetabular Shell BVI1689 (EP1) - Iris Ring BVI1689 (EP1) - Iris Ring & Inserter MicroSurg4751 (BP) - Malyugin RIng NovoSci7187 (EP1) - Catheter, cannula and tubing, vascular, cardiopulmonary bypass NovoSci7187 (EP1) - Instruments, Surgical, Cardiovascular Anodyne3068 (LN, LS) - PEYMAN BVI1689 (EP1) - Soft Tip Cannula BVI1689 (EP1) - LASIK Irrigating Cannula BVI1689 (EP1) - Flexible Tip Cannula BVI1689 (EP1) - Visitec Nucleus Hydrodissector BVI1689 (EP1) - Micro J Shape Cannula BVI1689 (EP1) - Irrigating Cystotome BVI1689 (EP1) - Anterior Chamber Cannula [Rycroft] BVI1689 (EP1) - Viscoflow Cannula BVI1689 (EP1) - Cortical Cleaving Hydrodissector BVI1689 (EP1) - Infusion Cannulas BVI1689 (EP1) - Lacrimal Cannula SonomedEscalon8890 (MN) - Viscous Fluid Cannula Ortho1399 (SN,EP1) - Headloc Alumina and Zirconia Ceramic Heads Ursel11054 (MN) - TRU-CLOSE Suction Drainage System Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System Ortho1399 (SN,EP1*) - Ortho Development Balanced Knee System Aspen1609 (MN,EP1) - Probe Cover Ortho1399 (SN,EP1) - Ceramic Femoral Heads NovoSci7187 (EP1) - Defoamer, cardiopulmonary bypass Avanos2508 (EP1,EP2) - AVANOS* Universal Block Trays Avanos2508 (EP1,EP2) - Prep Trays Avanos2508 (EP1,EP2) - Nerve Block Tray Avanos2508 (EP1,EP2) - Whitacre Needle Avanos2508 (EP1,EP2) - Single Shot Epidural Trays BVI1689 (EP1) - Eye Bandage BVI1689 (EP1) - Guibor Eye Bubble Bandage Ethicon (EP1) - Instrument, Ultrasonic Surgical Ortho1399 (SN,EP1) - Biolox Delta Ceramic Femoral Heads Ortho1399 (SN,EP1) - Vusion(R) OS Avanos2508 (EP1,EP2) - EASI-LAV BVI1689 (EP1, CH1) - Micro Flow Pre-Loaded Punctal Occluder Ortho1399 (SN,EP1) - Ovation Hip Stem NovoSci7187 (EP1) - Accessory Equipment, Cardiopulmonary Bypass Cordis1973 (EP1) - PRECISE PRO RX Nitinol Stent System NovoSci7187 (EP1) - Accessories, blood circuit, hemodialysis NovoSci7187 (EP1) - Catheter, cannula and tubing, vascular, cardiopulmonary bypass Ortho1399 (SN,EP1) - Solitude Unipolar Head Ethicon (EP1) - Harmonic 1100 Ethicon (EP1) - Instrument, Ultrasonic Surgical ErbeUSA9143 (SP, EP1) - Endo QuickConnect Pentax® Scope Port Connector Carefusion5709 (TM) - MSIII Administration Sets Carefusion5709 (TM) - MSIII HALF DEHP SMBORE INJ Carefusion5709 (TM) - MedSystem III Infusion Se Protech3048 (TM) - Vampiro Carefusion5709 (EP1) - SEC Set 20DP 30IN w/Hanger LL Carefusion (TM) - set, administration, intravascular Carefusion5709 (TM) - Medline IV Admin Set Carefusion (TM) - (NT) - Secondary Set Primo3300 (NR) - Nico BrainPath Approach Procedure Pack (Domestic US) BVI1689 (EP1) - Accu-Temp Zimmer (LS) - Creartions SCP Hip Kit Aspen1609 (EP1,MN) - Needle Guides, General Purpose Avanos2508 (EP1) - COOLIEF* Cooled Radiofrequency Kit Advanced Avanos2508 (EP1) - COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced Avanos2508 (EP1) - COOLIEF* Cooled Radiofrequency Probe Advanced Avanos2508 (EP1) - COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer Avanos2508 (EP1) - COOLIEF* Multi-Cooled Radiofrequency Kit Advanced Carefusion (EP1,SN,LS,NT) - Secondary Sets with Shrouded Needle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OJS Tourniquet Kit General, Plastic Surgery Class 1 878.5900 2013-01-28
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-11-14
HNL Probe, Lachrymal Ophthalmic Class 1 886.4350 2017-08-29
PSA Laparoscopic Jejunostomy Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
PPO Multi-Lumen Hemodialysis Catheterization Kit Gastroenterology, Urology Class 2 876.5540 2020-03-20
NYH Plaque Disclosing Kit Dental Class 2 872.1740 2013-01-28
PRT Gastric Irrigation And Aspiration Kit Gastroenterology, Urology Class 2 876.5980 2019-12-28
NWU Endoscope Introducer Kit Gastroenterology, Urology Class 2 876.1500 2013-01-28
NYF Gingival Retraction Kit Dental Class 1 872.4565 2013-01-28
OKE Port Introducer Kit General Hospital Class 2 880.5965 2013-01-28
PYK Venous Ulcer Kit General, Plastic Surgery Class 1 878.4014 2020-03-20
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-02-20
EBO Denture Repair Kit Dental Class 2 872.3570 2013-01-28
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular Class 2 870.4260 2024-11-15
MFY Endothelial Cell Harvesting Kit Cardiovascular Class 2 870.4075 2013-01-28
OKV Obstetrical Kit Obstetrics/Gynecology Class 2 884.4520 2013-01-28
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2015-02-19
PRQ Esophageal Dilator Kit Gastroenterology, Urology Class 2 876.5365 2020-03-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
OFU Spinal Anesthesia Kit Anesthesiology Class 2 868.5120 2013-01-28
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2013-01-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-04-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-12-31
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2024-11-15
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-11-14
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-22
KGC Tube, Gastro-Enterostomy Gastroenterology, Urology Class 2 876.5980 2012-10-31
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2012-10-31
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2024-11-15
HRX Arthroscope Orthopedic Class 2 888.1100 2021-08-26
OHO First Aid Kit Without Drug General, Plastic Surgery Class 1 878.4014 2013-01-28
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2013-01-28
PPB Foley Catheter Kit (Excludes Hiv Testing) Gastroenterology, Urology Class 2 876.5130 2020-03-20
OHG Circumcision Tray Obstetrics/Gynecology Class 2 884.4530 2013-01-28
LRQ Tracheostomy And Nasal Suctioning Kit Unknown Class 1 N/A 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
LZU Plug, Punctum Unknown Class U N/A 2020-11-10
PXP Breast Biopsy / Localization Tray General, Plastic Surgery Class 1 878.4800 2020-03-20
MLT Pelvic Exam Kit Obstetrics/Gynecology Class 2 884.4530 2013-01-28
HTO Reamer Orthopedic Class 1 888.4540 2013-01-07
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2022-04-23
PVU Obstetrical Anesthesia Kit Obstetrics/Gynecology Class 2 884.5100 2020-03-20
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2012-10-31
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-02-18
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-02-18
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2019-11-27
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-11-27
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-11-27
OHF Culdocentesis Kit Obstetrics/Gynecology Class 2 884.1640 2013-01-28
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-09-16
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2024-09-16
POQ Blood Transfusion Kit General Hospital Class 2 880.5440 2020-03-20
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-11-21
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2018-01-16
HMR Marker, Ocular Ophthalmic Class 1 886.4570 2012-12-28
OIN Prostate Seeding Kit Radiology Class 2 892.5730 2013-01-28
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2024-09-03
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-02-11
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-07
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-11-21
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2012-11-14
OKF Body Fluid Disposal Kit General, Plastic Surgery Class 2 878.4040 2013-01-28
LZU Plug, Punctum Unknown Class U N/A 2018-04-18
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
OEX Cardiovascular Catheter Sheath Introducer Kit Cardiovascular Class 2 870.1340 2013-01-28
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2012-10-31
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2012-10-31
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2012-10-31
OGS Myringotomy Procedure Kit Ear, Nose, Throat Class 2 874.3880 2013-01-28
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2013-01-28
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2019-11-17
PXD Prep Kit General Hospital Class 1 880.6250 2020-03-20
PXX Incision Tray General, Plastic Surgery Class 1 878.4800 2020-03-20
POZ Biopsy Needle Kit Gastroenterology, Urology Class 2 876.1075 2020-03-20
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-12-05
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2012-10-31
BYI Percussor, Powered-Electric Anesthesiology Class 2 868.5665 2012-10-31
HOG Burr, Corneal, Battery-Powered Ophthalmic Class 1 886.4070 2015-06-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-22
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2012-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
OFE Central Venous Blood Pressure Kit Cardiovascular Class 2 870.1140 2013-01-28
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology Class 1 876.1500 2018-11-06
OKG Body Fluid Clean Up Kit General, Plastic Surgery Class 2 878.4040 2013-01-28
PSJ Rectal Dilator Kit Gastroenterology, Urology Class 1 876.5450 2020-03-20
OFZ Blood Specimen Collection Kit (Excludes Hiv Testing) Anesthesiology Class 1 868.1100 2013-01-28
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2012-12-27
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-02-20
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2013-01-28
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-12-28
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-12-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-11-14
PPL Single Needle (Co-Axial Flow) Dialysis Kit Gastroenterology, Urology Class 2 876.5820 2020-03-20
EXB Collector, Ostomy Gastroenterology, Urology Class 1 876.5900 2012-10-26
OFV Regional Anesthesia Kit Anesthesiology Class 2 868.5120 2013-01-28
PSK Replacement Gastrostomy Feeding Catheter Tray Gastroenterology, Urology Class 2 876.5980 2020-03-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-23
PWO Blood Administration Kit General Hospital Class 2 880.5440 2020-03-20
OGK Orotracheal Intubation Guide Kit Anesthesiology Class 2 868.1400 2013-01-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-08-13
PVT Maternity Kit Obstetrics/Gynecology Class 1 884.5435 2020-03-20
OEV Cardiopulmonary Resuscitation Aid Kit Anesthesiology Class 2 868.5915 2013-01-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2013-01-28
OFO Airway Suction Kit Anesthesiology Class 1 868.6810 2013-01-28
KGE Forceps, Biopsy, Electric Gastroenterology, Urology Class 2 876.4300 2012-10-31
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2018-11-15
LKN Separator, Automated, Blood Cell And Plasma, Therapeutic Unknown Class U N/A 2012-11-15
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2019-11-19
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-10-31
PRV Gastro-Urology Biopsy Kit Gastroenterology, Urology Class 2 876.1075 2019-12-21
KYP Snake Bite Suction Kit General Hospital Class 1 880.5740 2012-12-27
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-11-13
PPQ Transtibial Anterior Cruciate Ligament Kit Orthopedic Class 2 888.3040 2020-03-20
OFN Winged Intravenous Catheterization Kit Cardiovascular Class 2 870.1200 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-08
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2025-04-02
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2012-11-14
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2019-12-31
MRZ Accessories, Pump, Infusion General Hospital Class 2 880.5725 2022-05-23
PXY Irrigation Kit (Wounds) General, Plastic Surgery Class 1 878.4014 2020-03-20
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2012-12-19
PFU Tissue Processing Kit Unknown Class N N/A 2020-03-20
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2021-07-09
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2022-08-13
OFY Dental Implant Surgical Tray Dental Class 1 872.3980 2013-01-28
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-12-19
OJJ Burn Kit Without Drug General, Plastic Surgery Class 1 878.4022 2013-01-28
NYG Lapping Tool Kit Dental Class 1 872.4565 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-12-28
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2021-07-09
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2013-12-24
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2013-01-28
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2012-12-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-11-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-11-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-02-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2017-12-18
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2017-12-18
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2017-12-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-12-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-07
OHE Forensic Evidence Sexual Assault Kit Obstetrics/Gynecology Class 2 884.1630 2013-01-28
PXW Herniorraphy Kit General, Plastic Surgery Class 1 878.4800 2020-03-20
PXI Thoracentesis Tray General Hospital Class 2 880.5570 2020-03-20
OII Arthrogram Tray Radiology Class 2 892.1650 2013-01-28
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-12-19
LZU Plug, Punctum Unknown Class U N/A 2015-06-28
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2012-12-27
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-04-02
LWE Bone Marrow Collection/Transfusion Kit Unknown Class 2 N/A 2013-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-19
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2024-03-14
PXG Spill Kit General Hospital Class 1 880.6890 2020-03-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-11-14
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-06-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-06-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-06-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2024-11-15
PRR Feeding Tube Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
OET Cardioplegia Solution Administration Kit Cardiovascular Class 2 870.4240 2013-01-28
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2022-08-13
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2022-08-13
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-11-14
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2023-03-24
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2012-12-27
OFS Tracheal Suction Set Anesthesiology Class 1 868.6810 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2024-11-15
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2019-12-31
OFL Percutaneous Sheath Introducer Kit Cardiovascular Class 2 870.1340 2013-01-28
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-11-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-04-20
PPI Hemodialysis Tray (Not A Start/Stop Kit) Gastroenterology, Urology Class 2 876.5820 2020-03-20
OFJ Lead Introducer Kit Cardiovascular Class 2 870.1340 2013-01-28
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-08-14
PSB Nasogastric Feed Tube Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-15
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2022-07-15
PRY Gastrostomy Jejunostomy Feeding Tube Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2024-11-15
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2012-10-31
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2012-12-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2012-10-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-19
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2012-12-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-11-14
PWY Lumbar Puncture Tray (Adult & Pediatric) General Hospital Class 2 880.5570 2020-03-20
PIN Kidney Perfusion Kit Gastroenterology, Urology Class 2 876.5880 2020-03-20
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2013-01-28
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2012-11-08
PWZ Mid-Stream Collection Kit General Hospital Class 1 880.6730 2020-03-20
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-01-05
LRS I.V. Start Kit General Hospital Class 2 880.5200 2013-01-28
NWP Suprapubic Cystostomy Catheter Kit Gastroenterology, Urology Class 2 876.5090 2018-09-24
MLS Labor And Delivery Kit Obstetrics/Gynecology Class 2 884.4530 2013-01-28
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-10-23
PYC Paracentesis Tray General, Plastic Surgery Class 1 878.4200 2020-03-20
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-11-14
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2012-12-19
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2022-04-23
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2012-10-31
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2012-11-15
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2023-12-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2023-12-20
PVX Vaginal Examination Tray Obstetrics/Gynecology Class 2 884.4530 2020-03-20
HXD Clamp General, Plastic Surgery Class 1 878.4800 2018-03-01
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2024-11-15
PXK Vascular Access Port Kit General Hospital Class 2 880.5965 2020-03-20
POR Parenteral Administration Kit General Hospital Class 2 880.5440 2020-03-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-02-18
PPC Male External Catheterization Kit (Excludes Hiv Testing) Gastroenterology, Urology Class 2 876.5130 2020-03-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-04-02
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2013-12-24
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-11-15
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-07
PRP Balloon Gastrostomy Tube Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2025-08-27
PXZ Laparascopic Sphincterotomy Kit General, Plastic Surgery Class 1 878.4800 2020-03-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2012-12-27
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2018-01-25
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2013-01-28
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2012-12-27
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2022-04-23
PVO Lumbar Drainage Catheter Kit Neurology Class 2 882.5550 2020-03-20
OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2013-01-28
PXU Fluid Drainage Tray General, Plastic Surgery Class 1 878.4200 2020-03-20
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-10-23
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-22
PWL Oral Surgery Tray Dental Class 1 872.4565 2020-03-20
LZU Plug, Punctum Unknown Class U N/A 2015-06-28
OGQ Ear Irrigation Kit General Hospital Class 1 880.6960 2013-01-28
PSG Percutaneous Endoscopic Gastrostomy Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-22
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2015-12-17
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-11-14
OFB Catheter Guide Wire Kit Cardiovascular Class 2 870.1330 2013-01-28
OKI Emergency Response Safety Kit General, Plastic Surgery Class 2 878.4040 2013-01-28
KPE Container, I.V. General Hospital Class 2 880.5025 2012-11-15
OJR Vacuum Powered Body Fluid Collection Kit General, Plastic Surgery Class 2 878.4780 2013-01-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2012-12-27
HAM Apparatus, Electrosurgical General, Plastic Surgery Class 2 878.4400 2013-02-11
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-12-18
PYL Wound Drainage Kit General, Plastic Surgery Class 1 878.4014 2020-03-20
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2024-11-15
HQR Apparatus, Cautery, Radiofrequency, Ac-Powered Ophthalmic Class 2 886.4100 2012-12-28
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2023-08-25
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2019-11-19
PSP Intracranial Pressure & Temperature Monitoring Kit Neurology Class 2 882.1620 2020-03-20
OHC Obstetrical Vacuum Delivery Kit Obstetrics/Gynecology Class 2 884.4340 2013-01-28
FFP Dilator, Rectal Gastroenterology, Urology Class 1 876.5450 2012-12-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-11-15
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2003-05-01
HRX Arthroscope Orthopedic Class 2 888.1100 2021-08-26
PPJ Peritoneal Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5630 2020-03-20
PPK Peritoneal Dialysis Tubing Kit Gastroenterology, Urology Class 2 876.5630 2020-03-20
PPA Bladder Irrigation Kit Gastroenterology, Urology Class 2 876.5130 2020-03-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2014-06-20
OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat Class 1 874.4420 2013-01-28
OXQ Dressing Change Tray General Hospital Class 1 880.5075 2013-01-28
OGW Tracheostomy Kit Anesthesiology Class 2 868.5800 2013-01-28
PKD Laceration Tray General, Plastic Surgery Class 1 878.4014 2020-03-20
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-08
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-08
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2012-10-31
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2018-02-20
OHH Breast Pump Kit Obstetrics/Gynecology Class 2 884.5160 2013-01-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-23
OID Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) Microbiology Class 1 866.2900 2013-01-28
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2022-04-25
NYE Fixture Mount Kit Dental Class 1 872.3980 2013-01-28
OHR Catheter Care Tray Gastroenterology, Urology Class 2 876.5130 2013-01-28
KZL Device, Warming. Blood And Plasma Hematology Class 2 864.9205 2018-01-25
PYD Pelviscopy Kit General, Plastic Surgery Class 1 878.4800 2020-03-20
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-08-14
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2012-12-19
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2001-08-06
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-02-18
OJA Intravenous Extension Tubing Set General Hospital Class 2 880.5440 2018-09-24
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-04-02
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2021-08-26
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2024-11-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-06-21
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-06-21
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-06-21
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2022-04-23
OGL Oxygen Administration Kit Anesthesiology Class 2 868.5655 2013-01-28
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-11-14
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2012-12-27
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2012-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
OFF Central Venous Catheter Tray Cardiovascular Class 2 870.1140 2013-01-28
OGI Nasal Endotracheal Tube Holder Kit Anesthesiology Class 1 868.5770 2013-01-28
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2017-11-13
PYF Sterile Puncture Tray General, Plastic Surgery Class 1 878.4800 2020-03-20
OGT Oral Irrigation Kit Dental Class 1 872.6510 2013-01-28
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2022-08-22
OGG Humidifier Nebulizer Kit Anesthesiology Class 2 868.5450 2013-01-28
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-11-15
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-04-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2015-02-19
OKZ Endometrial Sampling Kit Obstetrics/Gynecology Class 2 884.1175 2013-01-28
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2022-04-22
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2023-12-14
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2013-01-28
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2012-12-27
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2014-03-14
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2012-10-31
OFH Digital Angiography Tray Cardiovascular Class 2 870.1650 2013-01-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
PVP Neurological Test Kit Neurology Class 1 882.1750 2020-03-20
LZU Plug, Punctum Unknown Class U N/A 2015-05-01
PXJ Umbilical Catheter Insertion Tray General Hospital Class 2 880.5200 2020-03-20
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-02-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-02-18
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-11-27
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2020-08-14
OEU Cardiopulmonary Bypass Catheter Kit Cardiovascular Class 2 870.4210 2013-01-28
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-07-15
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2022-07-15
PPR Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures Orthopedic Class 2 888.1100 2020-03-20
NIO Stent, Iliac Unknown Class 3 N/A 2012-11-14
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2013-01-28
LZU Plug, Punctum Unknown Class U N/A 2018-04-18
PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse Obstetrics/Gynecology Class 2 884.4910 2020-03-20
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-12-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-12-18
HOC Clip, Iris Retractor Ophthalmic Class 1 886.4350 2012-12-28
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-11-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2017-11-13
PYJ Ulcer Wound Tray General, Plastic Surgery Class 1 878.4014 2020-03-20
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-04-02
PVL Endoscopic Shunt Placement Kit Neurology Class 2 882.5550 2020-03-20
PSD Laparoscopic Gastrostomy Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-11-14
OVN Suture Kit General, Plastic Surgery Class 2 878.4830 2013-01-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2022-04-22
OFW Restorative Instrument And Component Tray Dental Class 2 872.3690 2013-01-28
OFQ Anesthesia Kit Anesthesiology Class 2 868.5120 2013-01-28
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-04-02
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2017-11-13
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2024-11-15
NIM Stent, Carotid Unknown Class 3 N/A 2021-01-12
PQD Blood Specimen Collection Convenience Kit (Excludes Hiv) Clinical Chemistry Class 2 862.1675 2020-03-20
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2012-12-27
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-11-21
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-21
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2024-01-25
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-11-14
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2017-11-13
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
OGF Glossopharyngeal Anesthesia Kit Anesthesiology Class 2 868.5120 2013-01-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-02-18
DTP Defoamer, Cardiopulmonary Bypass Cardiovascular Class 2 870.4230 2024-11-15
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2024-11-15
OGC Continuous Brachial Plexus Block Tray Anesthesiology Class 2 868.5150 2013-01-28
PYG Suction Catheter Kit General, Plastic Surgery Class 1 878.4200 2020-03-20
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2012-12-27
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2012-10-31
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2013-01-30
OIA Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing) Pathology Class 1 864.3250 2013-01-28
OGD Custom Anesthesia Tray Anesthesiology Class 2 868.5120 2013-01-28
OFK Percutaneous Atrial Catheter Kit Cardiovascular Class 2 870.1250 2013-01-28
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-10-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-11-14
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2022-07-15
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2013-01-28
OFR Tracheobronchial Suction Catheter Kit Anesthesiology Class 1 868.6810 2018-09-24
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2021-07-09
OFI Laser Blood Flow Kit Cardiovascular Class 2 870.2120 2013-01-28
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2021-07-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-19
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-11-14
KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration Gastroenterology, Urology Class 2 876.5980 2022-04-23
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2021-07-09
LZU Plug, Punctum Unknown Class U N/A 2015-06-28
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-11-13
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2012-12-27
OHZ Urine Transport Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2013-01-28
OGU Pierced Ear/Entry Cleaning Tray Ear, Nose, Throat Class 1 874.4420 2013-01-28
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2012-12-19
KRI Accessory Equipment, Cardiopulmonary Bypass Cardiovascular Class 1 870.4200 2025-11-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-11-14
OKW Seminal Fluid Collection Kit Obstetrics/Gynecology Class 2 884.5300 2013-01-28
OKH Body Fluids Barrier Kit General, Plastic Surgery Class 2 878.4040 2013-01-28
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-11-14
PSC Nasogastric-Gastrojejunal Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
OFM Phlebotomy Blood Collection Kit Cardiovascular Class 2 870.2750 2013-01-28
NIM Stent, Carotid Unknown Class 3 N/A 2012-11-14
PAD Chest Drainage Kit General Hospital Class 2 880.6740 2020-03-20
PXF Sitz Bath Kit General Hospital Class 1 880.6730 2020-03-20
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2018-09-24
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-07
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2022-04-07
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2022-04-07
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2024-11-15
MAC Decontamination Kit General, Plastic Surgery Class 1 878.4014 2013-01-28
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2024-11-15
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2012-12-19
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2020-05-14
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2020-05-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-05-14
PZG Surgical Eye Tray Ophthalmic Class 1 886.4350 2020-03-20
OHL Pap Smear Kit Obstetrics/Gynecology Class 2 884.4530 2013-01-28
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-08-14
LKB Pad, Alcohol, Device Disinfectant Unknown Class U N/A 2012-11-09
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2018-04-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
FRN Pump, Infusion General Hospital Class 2 880.5725 2014-09-25
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2014-06-20
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2012-12-27
PWM Admission Kit (Patient Utensil) General Hospital Class 1 880.6730 2020-03-20
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
PPD Universal Drainage Tray Gastroenterology, Urology Class 2 876.5130 2020-03-20
OJG Neurological Tray Neurology Class 1 882.4525 2013-01-28
HQP Unit, Cautery, Thermal, Battery-Powered Ophthalmic Class 2 886.4115 2017-08-29
KNX Collector, Urine, (And Accessories) For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2012-12-27
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2012-11-15
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-04-12
OIC Blood Alcohol Kit (Excludes Hiv Testing) Clinical Toxicology Class 2 862.3040 2013-01-28
PVM Endoscopic Ventricular Catheter Placement Kit Neurology Class 2 882.4100 2020-03-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-04-02
PRU Gastric Lavage Kit (Adult Or Pediatric Use) Gastroenterology, Urology Class 2 876.4370 2020-03-20
FPD Tube, Feeding Gastroenterology, Urology Class 2 876.5980 2022-04-22
KPE Container, I.V. General Hospital Class 2 880.5025 2012-11-15
HNH Ring, Ophthalmic (Flieringa) Ophthalmic Class 1 886.4350 2012-12-28
OJK Eye Tray Ophthalmic Class 2 886.4790 2013-01-28
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2022-04-24
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2013-01-28
FNY Basin, Emesis General Hospital Class 1 880.6730 2012-12-27
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2022-04-21
FLK Thermometer, Clinical Mercury General Hospital Class 2 880.2920 2012-12-27
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2012-12-27
OKX Trocar Kit Obstetrics/Gynecology Class 2 884.1720 2013-01-28
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-08-13
PKE Laparoscopic Cholecystectomy Kit General, Plastic Surgery Class 1 878.4800 2020-03-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-03-12
OKU Emergency Obstetrical Kit Obstetrics/Gynecology Class 1 884.4520 2013-01-28
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2013-01-28
OIP Radiology-Diagnostic Kit Radiology Class 2 892.1680 2013-01-28
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2022-04-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
OFX General Purpose Dental Tray Dental Class 1 872.6640 2013-01-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2021-02-18
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-02-18
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-02-18
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2021-02-18
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-02-18
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2014-11-07
PVY Vasovasostomy Set Gastroenterology, Urology Class 1 876.4730 2020-03-20
PKF D And C Tray Unknown Class N N/A 2020-03-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-11-14
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-10-24
PRW Gastrointestinal Tube Kit Gastroenterology, Urology Class 2 876.5980 2020-03-20
CBT Arterial Blood Sampling Kit Anesthesiology Class 1 868.1100 2013-01-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2012-11-14
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-11-14
PPH Single Needle With Uni-Directional Pump Kit Gastroenterology, Urology Class 2 876.5820 2020-03-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3018811167 MEDIVATORS INC Rogers, MN, US
3038285067 Synergy Sterilisation Kulim (M) Sdn. Bhd Seberang Perai Selatan Pulau Pinang, MY
3031571464 Herotron E-Beam Service GmbH Bitterfeld Saxony-Anhalt, DE
3010897183 Synergy Health Marseille SAS CHUSCLAN Gard, FR
3008252486 ELECTRON BEAM SDN BHD Port Klang Selangor, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K252512 ABBOTT MEDICAL Armada™ 14 NC PTA Catheter 2026-02-13
K142654 Covidien, LLC Fortrex 0.035 OTW PTA Balloon Catheter 2014-10-28
K202800 Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) Pacific Plus PTA Catheter 2020-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019 Smith & Nephew, Inc. 2
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017 Zimmer Biomet, Inc. 2
Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019 Smith & Nephew, Inc. 2
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326
Z-0013-06 Plus Orthopedics USA 2
TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1643817. Last updated year: 2026. Please use registration number 1643817 when referencing this establishment in official correspondence.
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