ISOMEDIX OPERATIONS INC.

FDA Device Registration & Listing · SPARTANBURG, SC, US · Registration 1047843

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
1047843
FEI Number
1047843
Entity Name
ISOMEDIX OPERATIONS INC.
City/State/Country
SPARTANBURG, SC, US
Establishment Address
2072 Southport Rd, SPARTANBURG, SC 29306, 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

Carefusion (SP) - Electrodes VMuller7956 (SP) - Snowden-Pencer Diamond-Line (ST-MF,RR, WM-FE,RR); Snowden-Pencer Scissors (WM-FE,RR) Robling1585 (SP) - Misonix Inc. neXus Ultrasonic Surgical Aspirator System EndoTheia11104 (SP,CH1*) - FlexStone Basket AccessPoint5418 (MN) - Map-iT VerathonMedical5877 (WT) - GlideRite Single-Use Stylet - Small VerathonMedical5877 (TM) - GlideScope BFlex Sinlge-Use Bronchoscope System US_Endoscopy4223 (SP) - Endoscopic Tip Protector QTI7873 (SP) - Skintestor OMNI Robling1585 (SP) - Fibulink Syndemosis Repair Kit/SS Instylla8045 (SP) - Instylla Microcatheter 1.2 US_Endoscopy4223 (SP) - UroSeal adjustable endoscopic valve (00913410) (EN-CFE) StrykerSustainability (SP) - Hemo-Force Calf Garment Small StrykerSustainability (SP) - Hemo-Force Calf Garment Medium StrykerSustainability (SP) - Hemo-Force Calf Garment Bariatric StrykerSustainability (SP) - Vaso/Hemo Force Foot Garment Medium StrykerSustainability (SP) - Hemo-Force Calf Garment Large StrykerSustainability (SP) - Hemo-Force Thigh Garment Medium StrykerSustainability (SP) - Hemo-Force Thigh Garment Large StrykerSustainability (SP) - Vaso/Hemo Force Foot Garment Large Aquabiliti1563 (SP,GR) - Saline-filled flush syringe ErbeUSA9143 (SP, EP1) - Endo QuickConnect Pentax® Scope Port Connector TransMedics4216 (NR,SP*) - OCS Lung System Pretium1202 (WT) - Leakbuster PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag with Procedure Pack (Ref 622281) PFMMedical6614 (TM) - ASEPT 2000mL Drainage Bag (Ref 622280) Merit1383 (SN) - Cultura Saliva Self Collection Kit PFMMedical6614 (TM) - ASEPT 2,000mL Drainage Bag (Ref M7058) PFMMedical (TM) - ASEPT 2,000mL Drainage Bag with Procedure Pack (Ref M7060) CorningME1979 (CH1) - Corning Closed Systems individually wrapped centrifuge tubes and accessories BD4590 (SP) - BD Vacutainer® No Additive (Z) Plus Tubes Protech3048 (TM) - PHANTOM ML LIGHT CABLE Remington4376 (SP) - Illumination Systems BD4590 (SP) - BD Vacutainer® Serum Blood Collection Tubes 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 Atrion1619 (SP) - QL Inflation Device Atrion1619 (SP) - Sphere Inflation Device MicroPortOrtho6872 (SP) - Bipolar Shell Instylla8045 (SP) - Instylla Delivery Kit Robling1585 (SP) - AngiAssist Medical Gas Management and Delivery System BeInnovative11045 (LN) - Rotolock Cord Management System Hydrofera (NR, WH) - Instrument Wipe SurgicalTech4007 (LS) - FlexiTip, FlexiTip XL, FlexiTip XL-R Etex2142 (NR) - Precision Cannula 150 mm PhoenixMed2991 (SP) - Various Instruments Acuderm1463 (WH,LS) - Acu-Dispo-Ce PhoenixMed2991 (SP) - Instrument, manual, surgical, general use Abyrx4508 (WH) - Abyrx Putty Applicator Protech3048 (TM) - INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Protech3048 (TM) - PHANTOM ML LIGHT CABLE Design2052 (NR) - CTS Relief Kit US_Endoscopy4223 (SP) - Moray micro forceps US_Endoscopy4223 (SP) - Talon Grasping Device Atrion1619 (SP) - QL Inflation Device Atrion1619 (SP) - Ql Inflation Dveice Atrion1619 (SP) - Sphere Inflation Device Zimmer (LN, LS) - Trauma Fixation Systems Robling1585 (SP) - Fibulink Removal Kit Atrion1619 (SP) - QL Inflation Device US_Endoscopy4223 (SP) - Lariat snare US_Endoscopy4223 (SP) - Coin Tip Snare Aquabiliti1563 (SP,GR) - Saline, vascular access flush US_Endoscopy4223 (SP) - Torrent irrigation scope connector - Pentax US_Endoscopy4223 (SP) - Torrent irrigation tubing 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 AdvancedInnovation8660 (SP) - Libertas BiPolar Hip System Robling1585 (SP) - Sample Extraction Tools 230-600 Robling1585 (SP) - Sample Extraction Tools 200-200 Robling1585 (SP) - Sample Extraction Tools 230-400 Robling1585 (SP) - Brushes for Flexible Endoscope Culture Kit BaxterCR10745 (SP) - ONE-LINK StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Bariatric StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Small StrykerSustainability (SP) - Venaflow Elite Foam Calf Cuff Green StrykerSustainability (SP) - Venaflow Elite Calf Cuff Single Hose StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Large StrykerSustainability (SP) - Venaflow Elite XL Calf Cuff Single Hose StrykerSustainability (SP) - Vaso/Hemo Force Sequential Calf Garment Medium StrykerSustainability (SP) - Plexipulse Foot Wrap StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Medium StrykerSustainability (SP) - Vaso-Force Sequential Thigh Garment Large StrykerSustainability (SP) - VenaFlow Elite Thigh Cuff Single Hose StrykerSustainability (SP) - enaFlow Foam Calf Cuff Dual Hose StrykerSustainability (SP) - VenaFlow Elite Foot Garment Single Hose StrykerSustainability (SP) - VenaFlow Foot Garment with Pos Lock Up to 16" StrykerSustainability (SP) - Flowtron Thigh Garment Thigh StrykerSustainability (SP) - Foot Garment - One Pair Regular StrykerSustainability (SP) - Alternating Leg Pressure Pair Calf Large StrykerSustainability (SP) - Calf Garment - One Pair Regular StrykerSustainability (SP) - VenaFlow Disposable Thigh Cuff StrykerSustainability (SP) - Vaso Press Calf Compression Sleeve Large up to 24" StrykerSustainability (SP) - VenaFlow Calf Garment with Pos Lock Up to 19" StrykerSustainability (SP) - Foot Sleeve up to 14.5" StrykerSustainability (SP) - Thigh Sleeve Medium StrykerSustainability (SP) - Vaso Press Calf Garment Medium Up to 18" StrykerSustainability (SP) - Alternating Leg Pressure Pair Thigh Regular StrykerSustainability (SP) - Thigh Garment - One Pair Large StrykerSustainability (SP) - Vaso Press Thigh Garment DVT Prophylaxis System Large / up to 36" StrykerSustainability (SP) - Calf Sleeve Medium StrykerSustainability (SP) - VenaFlow Disposable Foot Cuff StrykerSustainability (SP) - Vaso Press Calf Garment Large Up to 24" StrykerSustainability (SP) - Vaso Press Thigh Compression Sleeve Large up to 36" StrykerSustainability (SP) - Thigh Sleeve Large StrykerSustainability (SP) - Impad Rigid Sole Foot Cover Right and Left Foot Large StrykerSustainability (SP) - Calf Sleeve - Pair Fits up to 21 1/2 in Medium StrykerSustainability (SP) - VenaFlow Thigh Garment with Pos Lock Up to 29" StrykerSustainability (SP) - Calf Garment - One Pair Large StrykerSustainability (SP) - SCD Express Compression Sleeve Foot Cuff Regular StrykerSustainability (SP) - Vaso Press Thigh Compression Sleeve Medium up to 29" StrykerSustainability (SP) - Calf Sleeve Short StrykerSustainability (SP) - Alternating Leg Pressure Pair Calf Regular StrykerSustainability (SP) - Vaso Press Foot Garment Large StrykerSustainability (SP) - Calf Sleeve - Pair Large up to 25 1/2" StrykerSustainability (SP) - Vaso Press Foot Garment Foot Size up to US13 StrykerSustainability (SP) - Thigh Sleeve Small StrykerSustainability (SP) - Alternating Leg Pressure Pair Foot Regular Up to 12 EEE StrykerSustainability (SP) - Vaso Press Thigh Garment DVT Prophylaxis System Medium / up to 29" StrykerSustainability (SP) - Thigh Garment - One Pair Regular StrykerSustainability (SP) - VenaFlow Disposable Calf Cuff StrykerSustainability (SP) - Flowtron DVT Calf Garment Calf StrykerSustainability (SP)- Foot Garment - One Pair Large StrykerSustainability (SP) - Foot Garment Universal Large StrykerSustainability (SP) - VenaFlow Disp XL Calf Cuff StrykerSustainability (SP) - Calf Garment - One Pair Extra Large StrykerSustainability (SP) - Calf Sleeve Large StrykerSustainability (SP) - Vaso Press Calf Compression Sleeve Medium up to 18" StrykerSustainability (SP) - Impad Rigid Sole Foot Cover Right and Left Foot Regular StrykerSustainability (SP) - SCD Express Compression Sleeve Foot Cuff Large StrykerSustainability (SP) - VenaFlow XL Calf Garment with Pos Lock Up to 22" US_Endoscopy4223 (SP) - Oracle EUS latex balloon-Olympus radial US_Endoscopy4223 (SP) - Oracle EUS latex balloon-Olympus linear Zimmer (LN,LS) - Bit, drill StrykerPR3324 (GR, LS, VG) - Twinloop FLEX TM Drill StrykerPR3324 (GR, LS, VG) - TwinLoop FLEX Zimmer (LN,LS) - Cannulated toggle button drill 4.5 MM Zimmer (LN,LS) - Maxfire Zimmer (LN,LS) - Toggleloc Eagle1350 (NT,SN) - Drill OmegaSurgical (LSRTC) - BIT, DRILL OrchidUnique5936 (LN) - Bit, Drill - Omega ClearChoice10284 (SP) - NPWT Foam Wound Dressing Kits Instylla8045 (SP) - Instylla Microcatheter N8Med6658 (SP) - CeraShield™ Endotracheal Tube AtriCure2121 (SP) - EPi-Sense ST Guided Coagulation System ErbeUSA9143 (SP) - ERBEFLO 2 Endo QuickConnect Scope Port Connectors 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 US_Endoscopy4223 (SP) - Polypectomy Snares MicroPortOrtho6872 (LN,WH,SP) - AXIOM Second Generation Knee System US_Endoscopy4223 (SP) - Infinity Cytology Brush US_Endoscopy4223 (SP) - BioShield Biopsy Valve EUS Robling1585 (SP) - ViaLok Single Vial Access Device Vented US_Endoscopy4223 (SP) - Exacto cold snare Merit1383 (TM) - Worley Slitter Merit1383 (TM) - Transavalvular Insertion tool (TVI) Merit1383 (TM) - Contamination Sleeve Protech3048 (TM) - Helix Locking Tool (HLT), Model A001HELX Remington4376 (SP) - Surgical Cables 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 Robling1585 (SP) - truFreeze Cryo Ablation System Solventum14471 (SP) - 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) Paragon6351 (NR) - Weck EFX Shield Fascial Closure System MML1375 (SN) - MML Specimen Collection Swab Ensera7760 (GR,SP) - Sterile Flocked Swab Ensera7760 (GR,SP) - SteriPack Sterile Polyester Spun Swab Ensera7760 (LN,SP) - Sterile 3" Foam Swab with yellow handle v2 Puritan5503 (NR) - CaligSwab; HydraFlock; PurFlock Ultra; Puritan, Pur-Wraps; PurSwab SteriPackUSA7760 (SP) - Sterile Foam Swab with yellow handle Puritan5503 (NR) - Sterile Foam Tipped Applicator Puritan5503 (NR) - Hospital, Sterile Cotton Tipped Applicators Robling1585 (SP) - ClearTip Swab Ultra Thin Birchwood1772 (MN) - Scopettes JR Puritan5503 (NR) - Sterile Cotton Tipped Applicators Puritan5503 (NR) - Puritan, Sterile Polyester Tipped Applicators Remington4376 (SP) - TNMF-XXXX, TNMR-XXXX AtriCure2121 (SP) - AtriCure Dissector Atrion1619 (SP) - QL Inflation Device Robling1585 (SP) - HBBSD2000 Merit1383 (TM) - ReSolve Locking Drainage Catheter AmericanCatheter5917 (SP) - American Catheter Merit1383 (TM) - Cen-Step Centesis Catheter US_Endoscopy4223 (SP) - Roth Net Retrieval Devices-  Foreign Body Standard US_Endoscopy4223 (SP) - Roth Net Retrieval Devices- Foreign Body Universal US_Endoscopy4223 (SP) - Roth Net Retrieval Devices-Foreign Body Maxi B&LSurgical1668 (SP) - Akreos Single Use Insertion Device B&LSurgical1668 (SP) - Lens Guide, Intraocular US_Endoscopy4223 (SP) - AquaShield System CO2 US_Endoscopy4223 (SP) - AquaShield System-PENTAX US_Endoscopy4223 (SP) - Aquashield System CO2-Fujifilm US_Endoscopy4223 (SP) - AquaShield System CO2-Pentax AtriCure2121 (SP) - Isolator Synergy EnCompass Clamp and Guide System ErbeUSA9143 (SP, EP1) - ERBEFLO® Olympus® Scope Port Connector US_Endoscopy4223 (SP) - Articulator Injection Needle; Carr-Locke Injection Needle WellsLamont8889 (SP) - Wells Lamont Cut Resistant Surgical Glove Liners Femasys4487 (SP) - FemaSeed Intratubal Insemination Robling1585 (SP) - Clip, Implantable, Titanimum Robling1585 (SP) - neXus Ultrasonic Surgical Apirator System US_Endoscopy4223 (SP) - Infinity ERCP sampling device US_Endoscopy4223 (SP) - Histoguide wire-guided forceps US_Endoscopy4223 (SP) - BioShield Biopsy Valve ErbeUSA9143 (SP,EP1) - ERBEFLO CleverCap® Hybrid CO2 Tubing/Cap Set for Olympus® Scopes AdvancedInnovations8660 (SP) - Libertas E-XLPE Modular Liner Robling1585 (SP) - Pulse Lavage Systems US_Endoscopy4223 (SP) - Histolock Resection Device CarpusMed (SP) - NAR Compressed Gauze Hydrofera2363 (NR,WH) - Instrument Wipe ZMedica3625 (NR,WH) - Phokus Nonwoven Bandage CarpusMed (SP) - NAR S-Rolled Gauze Hollister (SP) - Urostomy Pouch Hollister (SP) - Center Point Lock; Compact; Conform 2; First Choice; HOLLISTER UROSTOMY BAGS Hollister (SP) - Impression - C; Karaya 5; Moderma Flex; New Image; Premier; Securi-T USA; Tandem Hollister (LN, LS) - Hollister Horizontal Tube Attachment Device BVI1689 (EP1) - Eye Bandage BVI1689 (EP1) - Guibor Eye Bubble Bandage BD4590 (SP) - BD Vacutainer® Serum Blood Collection Tubes Instylla8045 (SP) - Instylla Delivery Kit US_Endoscopy4223 (SP) - Defendo Fujifilm 700 series valve kits Anjon7772 (SP) - ANJON BREMER HALO SYSTEM US_Endoscopy4223 (SP) - Padlock Clip Defect Closure System US_Endoscopy4223 (SP) - Padlock Clip Pro-Select Defect Closure System Ensera7760 (SP) - ClarifEye Markers WolfX-Ray11781 (SP) - Steritatt S&N7125 (SP) - NoStingSkinPrep S&N7125 (SP) - Secura S&N7125 (SP) - SecuraNoStingBarrier Robling1585 (SP) - Arisure Dry Spike Hollister (LN, LS) - HOLLISTER STOMA BAGS; Hollister Wound Drainage Collectors; STOMA BAGS Hollister (LN, LS) - A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAINING WOUND MANAGEMENT; Hollister (SP) - New Image; Premier; Securi-T USA; Tandem Hollister (SP) -Adapt; Center Point Lock; Compact; Conform 2; Dansac; Drainable Pouch Clamp; DuoSoft; Fecal Collectors; First Choice; Hollister (SP) - Nova 2; NovaLife 1; NovaLife 1 GX+; NovaLife 2; NovaLife 2 GX+; Pouchkins; Premier;Restore;Securi-T USA Hollister (SP) - Conform 2; First Choice; HOLLISTER UROSTOMY BAGS; Impression - C; Karaya 5; Moderma Flex Hollister (SP) - HOLLISTER STOMA BAGS; Hollister Wound Drainage Collectors; STOMA BAGS;Center Point Lock; Compact; Hollister (LN,LS,SP) - A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAINING WOUND MANAGEMENT Hollister (SP) - Holligard; Hollister; Hollister Solo Stoma Cap; Invent; Karaya 5; m9; Moderma Flex; New Image; Hollister (SP) - Tandem; Urostomy Drain Tube Adapter; Loop Ostomy Bridge; A BAGS; HOLLISTER DRAINING WO; HOLLISTER DRAI Femasys4487 (SP) - FemCath Cornual Ballon Catheter WellsLamont8889 ( SP) - Cut-Tec or Wells Lamont Polyester/Wire Cut Resistant Glove Liner WellsTecSceptert Robling1585 (SP) - Clip, Implantable, Polymer Preferred3038 (SP) - Bag Decanters Atrion1619 (SP) - QL Locking Syringe Atrion1619 (SP) - QL Inflation Device US_Endoscopy4223 (SP) - Torrent Irrigation Tubing BD4590 (SP) - BD Vacutainer® Serum Separator (SST™) Blood Collection Tube Merit1383 (TM) - BIG60 Merit1383 (TM) -Basix Compak Inflation Device Merit1383 (TM) - BIG60 ALPHA Inlfation Device Femasys4487 (SP) - VariLock Balloon Inflation Syringe McFarlane6051 (SP) - PercuNav Coaxial Needle Tracker US_Endoscopy4223 (SP) - BioGuard Air/Water and Suction valves (00711780) (EN-SD) Robling1585 (SP) - TS3 Robling1585 (SP) - TS3 Sentara US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (3 pc kit) US_Endoscopy4223 (SP) - BioGuard air/water & suction valves-Olympus (4 pc kit) BVI1689 (EP1) - Beaver Replacement Teflon Block BVI1689 (EP1) - Corneal Trephine US_Endoscopy4223 (SP) - Reveal Distal Attachment Cap Cryolife1999 (SP) - BGST-16 16mm Spreader Tip Cryolife1999 (SP) - BGST-12 12mm Spreader Tip Cryolife1999 (SP) - BG3502 BioGlue 2 mL Cryolife1999 (SP) - BGAT-SY Mixing Tip Artivion10572 (SP) - BG3502 BioGlue 2 mL Artivion10572 (SP) - BG3510 BioGlue 10 mL Cryolife1999 (SP) - BioGlue Surgical Adhesive Artivion10572 (SP) - BG3515 BioGlue 5 mL Artivion10572 (LN,SP) - BG3502 BioGlue Surgical Adhesive, 2mL US_Endoscopy4223 (SP) - Roth Net - foreign body maxi US_Endoscopy4223 (SP) - Roth Net Platinum - polyp US_Endoscopy4223 (SP) - Roth Net retriever - 360 US_Endoscopy4223 (SP) -Roth Net - foreign body mini US_Endoscopy4223 (SP) - Roth Net Platinum - universal US_Endoscopy4223 (SP) - Roth Net - foreign body standard US_Endoscopy4223 (SP) - Roth Net retriever select US_Endoscopy4223 (SP) - Roth Net Retrieval Devices- Pediatric Merit1383 (TM) - Finale Radial Compression System DVL-Op6436 (TM) - BRCDXL-05 Breast Reduction Compression Device XL DVL-Op6436 (TM) - BRCD-05 Breast Reduction Compression Device Merit1383 (TM) - RADstat Radial Artery Compression Device PrecisionMedical (NR) - T-RING AtriCure2121 (SP) - Isolator Linear Pen AtriCure2121 (SP) - Isolator Transpolar Pen AtriCure2121 (SP) - Coolrail Linear Pen AtriCure2121 (SP) - Isolator Synergy Access Clamp AtriCure2121 (SP) - Isolator Synergy Surgical Ablation System AtriCure2121 (SP) - Isolator Synergy EnCompass Clamp and Guide System BD4590 (SP) - BD BACTEC™ Subculturing/Aerobic Venting Unit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2022-03-25
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2022-03-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-23
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2013-01-07
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2012-10-31
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2014-03-03
OCU Endoscopic Storage Cover Gastroenterology, Urology Class 2 876.1500 2020-02-08
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2018-11-30
LDH N/A N/A Class N/A N/A 2020-10-30
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-03-25
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-10-17
EYK Connector, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2015-11-30
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2018-04-19
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2016-09-14
NGT Saline, Vascular Access Flush General Hospital Class 2 880.5200 2022-05-12
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2012-11-16
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-08-14
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2023-02-06
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2024-02-22
FWP Prosthesis, Chin, Internal General, Plastic Surgery Class 2 878.3550 2025-02-28
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2022-08-23
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2022-08-23
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-08-23
MSB System And Accessories, Isolated Heart, Transport And Preservation Gastroenterology, Urology Class 2 876.5880 2024-08-29
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-02-26
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-12-02
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2012-11-14
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2014-03-03
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2022-08-23
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2022-08-23
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-08-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-04-18
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2018-03-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-03-02
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2018-03-02
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-03-02
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-03-02
PSQ Intracardiac Patch Or Pledget, Biologically Derived Cardiovascular Class 2 870.3470 2022-12-08
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2024-02-22
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-02-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-02-22
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2024-02-22
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-09-12
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-02-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-10-12
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-07
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-01-28
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2022-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-28
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2012-12-18
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2020-11-23
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2020-11-23
KXA Prosthesis, Hip, Femoral, Resurfacing Orthopedic Class 2 888.3400 2024-02-22
FRN Pump, Infusion General Hospital Class 2 880.5725 2014-04-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-03-02
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-03-02
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-10-17
KMK Device, Intravascular Catheter Securement General Hospital Class 1 880.5210 2012-11-07
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics Unknown Class U N/A 2022-03-25
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2013-02-11
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-12-28
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-02-22
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2024-02-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-02-22
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2018-02-11
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
HAM Apparatus, Electrosurgical General, Plastic Surgery Class 2 878.4400 2013-02-11
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-02-22
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-11-21
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2018-03-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-03-02
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2016-12-09
FGO Dislodger, Stone, Flexible Gastroenterology, Urology Class 2 876.4680 2016-12-08
MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea Unknown Class 3 N/A 2018-02-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2024-02-26
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-02-22
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2024-02-22
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2020-11-23
KOE Dilator, Urethral Gastroenterology, Urology Class 2 876.5520 2020-11-23
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2012-11-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
HWB Extractor Orthopedic Class 1 888.4540 2013-01-07
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2021-08-03
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2020-05-08
KZD Infusor, Pressure, For I.V. Bags General Hospital Class 1 880.5420 2019-09-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-23
NGT Saline, Vascular Access Flush General Hospital Class 2 880.5200 2019-12-31
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-03-25
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2016-11-17
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2016-12-09
LZU Plug, Punctum Unknown Class U N/A 2021-07-07
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2023-02-15
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2022-08-22
BYZ Trap, Sterile Specimen General Hospital Class 2 880.6740 2017-10-24
MRZ Accessories, Pump, Infusion General Hospital Class 2 880.5725 2022-05-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-05-09
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2022-05-09
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-05-09
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2022-05-09
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-08-23
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2022-08-23
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-06-11
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2011-11-11
FRO Dressing, Wound, Drug Unknown Class U N/A 2025-06-11
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-10-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-10-12
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-26
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2026-04-03
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2026-04-03
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-08-23
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2022-08-23
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2022-08-23
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2016-09-14
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2016-09-14
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2017-05-18
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2017-05-18
HTW Bit, Drill Orthopedic Class 1 888.4540 2012-12-27
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 2020-10-07
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2022-03-30
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2024-02-22
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-10-17
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2018-02-11
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-30
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-25
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-04-18
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2022-08-23
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-08-23
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2021-12-16
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2013-01-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-01-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2025-07-01
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-08-14
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2013-02-11
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2003-05-01
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2018-11-30
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2012-11-15
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2012-12-27
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2016-12-09
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2023-05-26
MIJ Needle, Tumor Localization General, Plastic Surgery Class 1 878.4800 2018-03-01
QVG Embolization Agent, Vascular Unknown Class 3 N/A 2025-11-25
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2022-12-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-04-18
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2022-11-19
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2022-11-24
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2022-11-24
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2022-11-24
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2022-11-24
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2022-11-24
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2022-11-24
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2022-11-24
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-24
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-04-18
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-02-06
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-02-06
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2016-12-08
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2023-09-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-23
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2013-02-11
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2016-12-09
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2012-12-27
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2012-11-16
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-23
MEA Pump, Infusion, Pca General Hospital Class 2 880.5725 2022-05-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-01-28
PZP Fluid Jet Removal System General, Plastic Surgery Class 2 876.4350 2023-12-04
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-09-16
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2022-11-24
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2022-11-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-24
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2022-11-24
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2022-11-24
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-24
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2020-08-14
OOL Electronic Depth Gauge Orthopedic Class 2 888.3030 2022-08-25
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2024-03-19
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2026-05-28
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2025-06-05
PLY Antimicrobial Drapes General, Plastic Surgery Class 2 878.4370 2025-06-05
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2018-02-22
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-12-01
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2012-11-14
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2018-03-01
BSK Cuff, Tracheal Tube, Inflatable Anesthesiology Class 2 868.5750 2022-11-24
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2022-11-24
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2022-11-24
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2020-10-22
FRO Dressing, Wound, Drug Unknown Class U N/A 2018-01-25
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2021-08-03
DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular Class 2 870.4400 2013-02-11
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2018-03-01
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-01-28
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2022-11-24
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2012-11-16
PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2012-12-28
OXE Mesh, Surgical, Collagen, Staple Line Reinforcement General, Plastic Surgery Class 2 878.3300 2012-12-28
OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery General, Plastic Surgery Class 2 878.3300 2012-12-28
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2012-12-28
PAJ Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2012-12-28
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2012-10-31
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-12-08
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2016-12-08
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2020-02-28
KYB Lens, Guide, Intraocular Ophthalmic Class 1 886.4300 2012-12-18
FWP Prosthesis, Chin, Internal General, Plastic Surgery Class 2 878.3550 2025-02-28
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2019-08-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-10-30
NQO Prosthesis, Spinous Process Spacer/Plate Unknown Class 3 N/A 2014-02-26
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2025-12-01
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2020-08-14
GCE Adaptor, Catheter General, Plastic Surgery Class 1 878.4200 2024-01-29
FRN Pump, Infusion General Hospital Class 2 880.5725 2012-11-16
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2020-11-23
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-11-24
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2026-02-25
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2012-10-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-03-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-03-21
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-03-21
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2023-05-24
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2023-05-24
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2023-10-12
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2013-02-11
KPE Container, I.V. General Hospital Class 2 880.5025 2012-11-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-07-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2015-06-09
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-02-22
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2024-02-22
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2024-04-15
SCL Allergen And Vaccine Delivery Needles General Hospital Class 2 880.5570 2020-12-03
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-02-22
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2024-02-22
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2016-12-09
EZP Rod, Colostomy Gastroenterology, Urology Class 2 876.4270 2019-12-30
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2018-02-07
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2018-11-30
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2012-12-27
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2023-09-07
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2023-09-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-03-25
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-08-23
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2020-08-14
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-08-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-03-02
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-05-09
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2022-05-09
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2022-05-09
EFQ Gauze/Sponge, Internal Unknown Class U N/A 2025-04-16
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2025-04-16
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2018-03-02
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-03-02
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) Orthopedic Class 3 888.3330 2018-03-02
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-03-02
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-02-26
HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2024-05-22
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2016-12-09
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-30
KPE Container, I.V. General Hospital Class 2 880.5025 2022-07-28
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-02-22
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2024-02-22
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2024-02-22
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-02-22
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 1992-12-02
EXG Bag, Urine Collecting, Ureterostomy Gastroenterology, Urology Class 1 876.5900 2022-12-27
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2022-06-30
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2020-10-19
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2018-06-06
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2018-06-06
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-07-28
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2022-07-28
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2013-01-30
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-08-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2022-11-24
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2025-11-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-26
SEL Securement Wound Dressing For Reduction Of Infection Unknown Class U N/A 2022-01-11
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-10-17
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2025-01-08
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-01-08
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2025-01-08
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-01-08
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-07-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-07-28
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2022-05-12
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2018-03-21
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2024-12-16
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2020-04-30
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2024-09-12
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 1994-04-11
KMF Bandage, Liquid General Hospital Class 1 880.5090 2012-11-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-03-02
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2018-03-02
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-03-02
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2022-03-25
HQM Keratoprosthesis, Permanent Implant Ophthalmic Class 2 886.3400 2021-12-13
GDS Bag, Stomal Gastroenterology, Urology Class 1 876.5900 2012-12-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-03-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2026-03-13
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2026-03-13
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2022-02-15
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2026-02-25
FZP Clip, Implantable General, Plastic Surgery Class 2 878.4300 2022-03-25
KPE Container, I.V. General Hospital Class 2 880.5025 2020-10-19
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-02-26
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2020-02-05
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-02-05
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-02-05
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2020-02-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-02-05
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2022-03-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-06-30
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2022-01-28
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2022-01-28
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-01-28
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2022-01-28
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2020-11-23
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2016-12-08
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2024-02-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-04-19
POD Temporary, Internal Use Hemostatic General, Plastic Surgery Class 2 878.4454 2022-03-25
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-04-18
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2022-05-23
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2020-10-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-04-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-11-09
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2020-11-09
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2020-11-09
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-11-24
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2025-11-24
PHC Infusion Safety Management Software General Hospital Class 2 880.5725 2018-01-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2018-01-04
FRN Pump, Infusion General Hospital Class 2 880.5725 2018-01-04
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2014-09-12
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2022-11-24
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2022-11-24
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2022-11-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-24
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-11-24
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2022-11-24
MOU Intravascular Radiation Delivery System Unknown Class 3 N/A 2012-12-18
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular Class 2 870.4210 2013-02-11
PRT Gastric Irrigation And Aspiration Kit Gastroenterology, Urology Class 2 876.5980 2019-12-28
JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) Orthopedic Class 3 888.3320 2024-02-26
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-10-31
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-28
KPE Container, I.V. General Hospital Class 2 880.5025 2012-11-15
FRO Dressing, Wound, Drug Unknown Class U N/A 2013-01-30
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2016-12-09
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-02-22
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2021-06-02
KMF Bandage, Liquid General Hospital Class 1 880.5090 2018-01-25
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2022-11-19
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-03-01
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-02-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-02-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-04-19
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2024-09-06
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2024-09-06
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2024-09-06
GXZ Electrode, Needle Neurology Class 2 882.1350 2024-09-06
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2024-09-06
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2024-09-06
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-04-18
MUQ Glue, Surgical, Arteries Unknown Class 3 N/A 2014-04-01
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2019-01-03
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-01-03
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2012-11-07
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-04-18
OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue General, Plastic Surgery Class 2 878.4400 2025-07-01
HBA Neurosurgical Paddie Neurology Class 2 882.4700 2025-04-16
JTA Monitor, Microbial Growth Microbiology Class 1 866.2560 2024-02-08
FPY Sheet, Burn General Hospital Class 1 880.5180 2012-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERIS Corporation
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Other Registrations for Same Entity

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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
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1047843. Last updated year: 2026. Please use registration number 1047843 when referencing this establishment in official correspondence.
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