Isomedix Operations, Inc.

FDA Device Registration & Listing · Temecula, CA, US · Registration 2030624

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
2030624
FEI Number
3000206435
Entity Name
Isomedix Operations, Inc.
City/State/Country
Temecula, CA, US
Establishment Address
43425 Business Park Dr, Temecula, CA 92590, 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

Merit1383 (TM) - Fluid Administration Set (FAS) Merit1383 (TM) - CT Transfer Merit1383 (TM) - PreludeSYNC Radial Compression Device Merit1383 (TM) - PreludeSYNC Distal Radial Compression Device Avanos2508 (TM) - EchoBright Echogenic PNB Needle Avanos2508 (TM) - EchoBright Echogenic Regional Block Needle with Injection Set Zenflow34605 (TM) - Zenflow Spring Implant and Delivery System Merit1383 (TM) - SafeSheath Sealing Adapter Biomerics6631 (LN) - StandTall Merit1383 (TM) - NeoVasc Avanos2508 (TM) - SELECT-A-FLOW* Avanos2508 (TM) - I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) VerathonMedical5877 (TM) - GlideScope BFlex 5.8 Sinlge-Use Bronchoscope System VerathonMedical5877 (TM) - GlideScope BFlex™ 5.8 Single-Use Bronchoscope System VerathonMedical5877 (TM) - GlideScope BFlex™ 2 Large 5.8 Single-Use Bronchoscope Protech3048 (TM) - Vein Pick Protech3048 (TM) - Slit Suture Sleeve Atrium1623 (NR) - Chest Drain Accessories Ursel11054 (MN) - Thora-Vent Thoracic Vent PFMMedical6614 (TM) - Asept; Jet-Vac LSO2556 (TM) - SurgiFish Viscera Retainer Merit1383 (TM) - Disposal Depot (MDD) Acumed4864 (TM) - Acu-Sinch Knotless SurgicalSpecialties6945 (TM) - Barbed PPN Sutures Carefusion (EP1) - SmartSite standalone and extension sets Carefusion5709 (EP1) - Alaris SmartSite Needle-Free Valve Carefusion5709 (TM) - Medline IV Admin Set Carefusion (NT) - set, administration, intravascular Ursel11054 (MN) - Optimus Merit1383 (TM) - Merit Drainage Depot Merit1383 (TM) - Merit MAK Merit1383 (TM) - Corvocet Coaxial Introducer 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 Carefusion5709 (TM) - Gravity Sets Carefusion5709 (TM) - Medline IV Admin Set Carefusion (NT) - Set, administration, intravascular Merit1383 (TM) - Prelude Prestige Splittable Sheath Introducer DVL-op6436 (TM) - Motiva Channel Separator 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 SurgicalSpecialties6945 (NT,TM) - Nylon Sutures Protech3048 (TM) - MY01-0001 MY01 Continuous Compartmental Pressure Monitor Protech3048 (TM) - MY01-0001 MY01 Continuous Compartmental Pressure Monitor Merit1383 (TM) - Dilators 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 LSO2556 (TM) - RFA-06022 Sonata Radiofrequency Ablation Handpiece Merit1383 (TM) - Corvocet Biopsy System Protech3048 (TM) - Falcon Protech3048 (TM) - IS-1/Quadripolar Terminal Cap Protech3048 (TM) - Stylet Kit Protech3048 (TM) - Stylet Model 4078 LSO2556 (TM) - SeromaCath Wound Drainage System LSO2556 (TM) - Sapphire Suction Reservoir Carefusion (NT,LS) - set, administration, intravascular; set, I.V., fluid transfer Carefusion5709 (TM) - Alaris Medical Infusion System Administration Sets- Merit1383 (TM) - K04 - Tubing Kit Merit1383 (TM) - K08- Fluid Management Kit Biophyx13655 (LN) - RETRACTOR DVL-opMEDICO6436 (TM) - RetraLight Merit1383 (TM) - Temno Evolution Merit1383 (TM) - K05 Inflation Kit SurgicalSpecialties6945 - (TM) DURAMESH Mesh Suture Avenu7784 (TM) - Ellipsys Vascular Access System Medtronic2686 (MN) - Ellipsys® Vascular Access System (Catheter) Protech3048 (TM) -  MicoTransponder Vivistim Paired VNS System (Vivistim System) PFMMedical (TM) - 4F x 20cm Single Lumen Midline (Ref PFM4SML20N) PFMMedical (TM) - 5F x 20cm Single Lumen Midline (Ref PFM5SML20) PFMMedical (TM) - 3F x 20cm Single Lumen Midline (Ref PFM3SML20N) PFMMedical (TM) - 5F x 20cm Dual Lumen Midline (Ref PFM5DML20) PFMMedical (TM) - 3F x 20cm Single Lumen Midline (Ref PFM3SML20) PFMMedical (TM) - 4F x 20cm Single Lumen Midline (Ref PFM4SML20) Merit1383 (TM) - Vessel Sizing Catheter (VSC) Protech3048 (TM) - Superhawk Protech3048 (TM) - Mustang Protech3048 (TM) - Eagle VerathonMedical5877 (TM) - GlideScope BFlex Sinlge-Use Bronchoscope System VerathonMedical5877 (TM) - GlideScope BFlex™ 5 Single-Use Bronchoscope System VerathonMedical5877 (TM) - GlideScope BFlex™ 2 Regular 5 Single-Use Bronchoscope PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Nursing Kit (Ref PFM2CT3SP) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC (Ref: PFM2CT3S) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC SV OTW Kit (Ref PFM2CT3SR) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Kit (Ref PFM2CT4DW) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Nursing Kit (Ref PFM2CT4DP) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC Nursing Kit (Ref: PFM2CT4DN) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Nursing Kit (Ref: PFM2CT3SN) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC SV OTW Kit (Ref PFM2CT4DR) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC OTW Kit (Ref: PFM2CT3SL) PFMMedical6614 (TM) - 3F x 45cm Single Lumen CT PICC Kit (Ref PFM2CT3SW) PFMMedical6614 (TM) - 4F x 50cm Dual Lumen CT PICC (Ref: PFM2CT4D) AbbotVasc (TM) - Dragonfly OpStar Imaging Merit1383 (TM) - Hydrophillic Prelude SNAP Splittable Sheath Introducer Puregraft8291 (TM) - Dermapose Refresh Protech3048 (TM) - PHANTOM ML LIGHT CABLE Remington4376 (SP) - Illumination Systems Protech3048 (TM) - AIM Sterile Inserts Olympus2295 (MN) - Uro Guide Merit1383 (TM) - DriPAD Super Absorbent Pad SurgicalSpecialties6945 (NT,TM) - Silk Sutures Protech3048 (TM) - Hex Wrench Protech3048 (TM) - Torque Driver Protech3048 (TM) - IS-1 Receptacle Plus Protech3048 (TM) - IS4/DF4 Port Plug Accessory Kit Protech3048 (TM) - Lead Cap (IS1/DF1/SJ4) Protech3048 (TM) - DF-1 Receptacle Plug 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 Spineology5627 (MN) - E Blades/Rakes Spineology5627 (MN) - SOAR Portal Tubes Protech3048 (TM) - Metaphyseal Kit, 5 Pack Spineology5627 (MN) - Retractor Protech3048 (TM) - Diaphyseal Kit, Single Spineology5627 (MN) - Duo Disposable Instruments Protech3048 (TM) - Universal Pin in Place Guide Protech3048 (TM) - Diaphyseal Kit, 5 Pack Merit1383 (TM) - SafeSheath CSG Introducer Sheath Kit BVI1689 (EP1) - Iris Ring BVI1689 (EP1) - Iris Ring & Inserter MicroSurg4751 (BP) - Malyugin RIng Natus2422 (TM) - Micro Ventricular Bold Pressure/Temperature Monitoring Kit, MOdule 110-4HMT Kurin7497 (TM) - Kurin Blood Culture Collection Set Avanos2508 (TM) - ProBloc, HN Series and Prolong, PL Series SurgicalSpecialties6945 (TM) - PCL Punctum Plugs Protech3048 (TM) - Suture Sleeve Accessory DS2A088 Merit1383 (TM) - 5.5F Worley Advanced LVI Lateral Vein Introducer SurgicalSpecialties6945 (TM) - Silicone Punctum Plugs Dravon8000 (TM) - BLUE T-CLAMP PFMMedical6614 (TM) - 6F x 60cm Triple Lumen CT PICC Nursing Kit (Ref: PFM2CT6TN) PFMMedical6614 (TM) - 6F x 60cm Triple Lumen CT PICC OTW Kit (Ref: PFM2CT6TL) PFMMedical6614 (TM) - 6F x 60cm Triple Lumen CT PICC (Ref: PFM2CT6T) PFMMedical6614 (TM) - 6F x 60cm Triple Lumen CT PICC Kit (Ref PFM2CT6TW) PFMMedical6614 (TM) - 5F x 55cm Triple Lumen CT PICC OTW Kit (Ref: PFM2CT5TL) PFMMedical6614 (TM) - 5F x 55cm Triple Lumen CT PICC (Ref: PFM2CT5T) PFMMedical6614 (TM) - 5F x 55cm Triple Lumen CT PICC Nursing Kit (Ref: PFM2CT5TN) PFMMedical6614 (TM) - 5F x 55cm Triple Lumen CT PICC Kit (Ref PFM2CT5TW) SurgicalSpecialties6945 (TM,NT) - Polyester Sutures Merit1383 (TM) - Temno ACT Merit1383 (TM) - Temno Original MPS34520 (TM) - BTF-HM-3, Hummingbird Trifurcated Extension Se Kurin7497 (TM) - Kurin Blood Culture Collection Set Natus2422 (TM) - Micro Ventricular Bolt Pressure Monitoring Kit, Model 110-4HM Carefusion5709 (TM) - MSIII Administration Sets Carefusion5709 (TM) - MSIII HALF DEHP SMBORE INJ Carefusion5709 (TM) - MedSystem III Infusion Se Protech3048 (TM) - Spirit Zeiss34518 (TM) - Intraocular Lenses Merit1383 (TM) - ReSolve Biliary Locking Drainage Catheter AccessSci5463 (TM) - POWERWAND XL 3Fr X 6cm, Introducer with Extended Dwell Catheter AccessSci5463 (TM) - PW ED 3Frx6cm, Safety Introducer w/Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL 3Fr X 6cm, Extended Dwell Catheter Protech3048 (TM) - Nighthawk PFMMedical6614 (TM) - Scripps 5F x 10cm Jet-Vac Procedure Trays (Ref: M7854SC) PFMMedical6614 (TM) - 4F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613211) PFMMedical6614 (TM) - Palomar 5F x 7cm Jet-Vac Procedure Trays (Ref M7853P) Ranfac3098 (NR) - GIU-30, 31G-END, 30G-END, GIU-31 PFMMedical6614 (TM) - 5F x 15cm Jet-Vac Centesis Catheter (Ref M7515) PFMMedical6614 (TM) - 4F x 7cm Jet-Vac Centesis Catheter (Ref M7511) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Safety Procedure Tray (Ref M7554NM) PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Centesis Catheter (Ref M7512) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Safety Procedure Tray (Ref M7554) Merit1383 (TM) - Mak-NV PFMMedical6614 (TM) - Palomar 5F x 10cm Jet-Vac Procedure Trays (Ref M7854P) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Centesis Catheter (Ref M7514) PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Safety Procedure Tray (Ref M7553) PFMMedical6614 (TM) - 5F x 15cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613214) PFMMedical6614 (TM) - Eisenhower 5F x 7cm Jet-Vac Procedure Tray (Ref M7853EI) PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Centesis Catheter (Ref M7513) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Procedure Tray (Ref M7854) PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Safety Procedure Tray (Ref M7552) PFMMedical6614 (TM) - 5F x 10cm Jet-Vac Procedure Tray (Ref 850007) PFMMedical6614 (TM) - 5F x 7cm Jet-Vac Procedure Tray (Ref M7853) PFMMedical6614 (TM) - Eisenhower 5F x 10cm Jet-Vac Procedure Tray (Ref M7854EI) PFMMedical6614 (TM) - 4F x 10cm Jet-Vac Procedure Tray (Ref M7852) PFMMedical6614 (TM) - 4F x 7cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613210) Ranfac3098 (NR) - Sialography Unit Endport PFMMedical6614 (TM) - 5F x 7cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613212) Merit1383(TM) - Introducer Needle with Trocar Stylet, PFMMedical6614 (TM) - 5F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage (Ref 613213) 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 Merit1383 (TM) - Pink Achieve Merit1383 (TM) - Achieve EdwardsLife6723 (TM) - MITRIS RESILIA Mitral Valve EdwardsLife6723 (MN,TM) - KONECT RESILIA Aortic Valved Conduit AtriCure2121 (SP) - AtriCure Dissector Protech3048 (TM) - Initia Total Hip System Protech3048 (TM) - Medical Adhesive SurgicalSpecialties6945 (TM) - PGA Sutures Merit1383 (TM) - Prelude Sheath Introducer MPS34520 (TM) - BTF-HM-3, DB-003-03, EA-036-01, EB-006-11, EB-012-01, EB-030-02, EB-030-13, EB-038-02 MPS34520 (TM) - EC-072-01, EG-013-01, EG-016-04, EH-047-01, KMI-02-06, KMI467C, KMI483C, KMI636 MPS34520 (TM) - EB-038-11, EB-045-03, EB-060-01, EB-060-27, EB-072-01, EB-072-02, EB-072-03, EB-112-01, EC-060-01 SurgicalSpecialties6945 (TM) - Barbed PDO Sutures PFMMedical6614 (TM) - 6F x 60cm Dual Lumen CT PICC Nursing Kit (Ref: PFM2CT6DN) PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC Nursing Kit (Ref PFM2CT4SP) PFMMedical6614 (TM) - 5F x 55cm Single Lumen CT PICC Kit (Ref PFM2CT5SW) PFMMedical6614 (TM) - 6F x 60cm Dual Lumen CT PICC Kit (Ref PFM2CT6DW) PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC OTW Kit (Ref: PFM2CT4SL) PFMMedical6614 (TM) - 5F x 55cm Dual Lumen CT PICC OTW Kit (Ref: PFM2CT5DL) PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC Kit (Ref PFM2CT4SW) PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC (Ref: PFM2CT4S) PFMMedical6614 (TM) - 6F x 60cm Dual Lumen CT PICC OTW Kit (Ref: PFM2CT6DL) PFMMedical6614 (TM) - 5F x 55cm Dual Lumen CT PICC Nursing Kit (Ref: PFM2CT5DN) PFMMedical6614 (TM) - 5F x 55cm Single Lumen CT PICC Nursing Kit (Ref: PFM2CT5SN) PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC SV OTW Kit (Ref PFM2CT4SR) PFMMedical6614 (TM) - 5F x 55cm Single Lumen CT PICC OTW Kit (Ref: PFM2CT5SL) PFMMedical6614 (TM) - 5F x 55cm Dual Lumen CT PICC (Ref: PFM2CT5D) PFMMedical6614 (TM) - 4F x 50cm Single Lumen CT PICC Nursing Kit (Ref: PFM2CT4SN) PFMMedical6614 (TM) - 5F x 55cm Dual Lumen CT PICC Kit (Ref PFM2CT5DW) PFMMedical6614 (TM) - 5F x 55cm Single Lumen CT PICC (Ref: PFM2CT5S) PFMMedical6614 (TM) - 6F x 60cm Dual Lumen CT PICC (Ref: PFM2CT6D) PFMMedical6614 (TM) - ASEPT Procedure Pack (Ref M7040) Merit1383 (SN, NT) - K13 Label Kit PFMMedical6614 (TM) - Jet-Vac Protech3048 (TM) - Shadow Merit1383 (TM) - Input SSV Merit1383 (TM) - Split Sheath Introducer Kit wih Valve, et al. PFMMedical6614 (TM) - 5.5F x 5cm Micro Introducer Kit (Ref M550540) PFMMedical6614 (TM) - 5.5F x 7cm Micro Introducer Kit (Ref M550740) PFMMedical6614 (TM) - 4.5F x 5cm Micro Introducer Kit (Ref M450540) PFMMedical6614 (TM) - 3.5F x 5cm Micro Introducer Kit (Ref M350540) PFMMedical6614 (TM) - 6.5F x 7cm Micro Introducer Kit (Ref M650740) PFMMedical6614 (TM) - 3.5F x 7cm Micro Introducer Kit (Ref M350740) PFMMedical6614 (TM) - 4.5F x 7cm Micro Introducer Kit (Ref M450740) PFMMedical6614 (TM) - 6.5F x 5cm Micro Introducer Kit (Ref M650540) Protech3048 (TM) - MY01-0001 MY01 Continuous Compartmental Pressure Monitor Zenflow34605 (TM) - Zenflow Spring Scope PFMMedical6614 (TM) - NuCath Auris9616 (TM) - Monarch Platform Avanos2508 (TM) - ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP Protech3048 (TM) - Suture Sleeve Protech3048 (TM) - IS4/DF4 Connector Sleeve Merit1383 (NT,SN,TM) - TruCut 18Ga Merit1383 (TM) - Aspira Pleural Drainage System Merit1383 (TM) - Performa Diagnostic Intravascular Catheter VerathonMedical5877 (TM) - GlideScope BFlex™ 3.8 Single-Use Bronchoscope System VerathonMedical5877 (TM) - GlideScope BFlex™ 2 Slim 3.8 Single-Use Bronchoscope SurgicalSpecialties6945 (TM) - Stainless steel Sutures Merit1383 (NT,SN) - StayFIX Fixation Device PFMMedical6614 (TM) - ASEPT Drainage Catheter Dressing Kit (Ref M7041) Ursel11054 (MN) - TRU-FIX Catheter Fixation Kit Insulet5490 (NR) - PodPals Adhesive Overlay Insulet5490 (NR) - Adhesive Overlay Merit1383 (TM) - Merit PAK Merit1383 (TM) - Impress Angiographic Catheter Merit1383 (TM) - Worley Merit1383 (SN) - SafeGuard Focus Compression Protech3048 (TM) - Valor Protech3048 (TM) - Lightning Protech3048 (TM) - Hornet Protech3048 (TM) - Super Hornet Protech3048 (TM) - Paratrooper™ Plantar Plate Repair System PFMMedical6614 (TM) - VETA Peritoneal Dialysis Introducer Kit (Ref M7230) Zenflow34605 (TM) - Zenflow Spring Implant Retrieval Device Protech3048 (TM) - MY01-0001 MY01 Continuous Compartmental Pressure Monitor PFMMedical6614 (TM) - ASEPT Pleural Drainage System (Ref M7001) PFMMedical6614 (TM) - ASEPT Pleural Catheter Kit (Ref 622289) PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref 622288) PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref 622286) Carefusion (NT) - Set, administration, intravascular Carefusion5709 (TM) - Alaris Extension Set- Merit1383 (TM) - Miser Contrast Management System Avanos2508 (TM) - HOMEPUMP ECLIPSE* Avanos2508 (TM) - SELECT-A-FLOW* Avanos2508 (TM) - ON-Q* Pump Avanos2508 (TM) - ON-Q Pain Relief System with Bolus PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter, Straight, Double Cuff (Ref M7100) PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter (Ref M7150) PFMMedical6614 (TM) - VETA Peritoneal Catheter Kit with Curled Catheter (Ref M7225) PFMMedical6614 (TM) - VETA Peritoneal Dialysis Catheter, Curled, Double Cuff (Ref M7200) Protech3048 (TM) - Vampiro MPS34520 (TM) - 19B, 19CHTP, 19MMTP, 19MTP, 19TP, 900490,900590 AccessSci5463 (TM) -POWERWAND XL 4Fr X 10cm, Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND 5Fr x 10cm Safety Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL 4Fr X 8cm, Introducer with Extended Dwell Catheter AccessSci5463 (TM) - Pouch, PW XL, 4FR, 10CM, CE AccessSci5463 (TM) - POWERWAND XL 5Fr x 8cm Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND AL-REC 4Fr x 6cm, Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL, 4Fr x 8cm Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND 4Fr X 10cm, Safety Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND 5Fr x 8cm Safety Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL 5Fr X 10cm, Introducer with Extended Dwell Catheter w Bifurcated Extension Set AccessSci5463 (TM) - POWERWAND XL 5Fr x 8cm Extended Dwell Catherter AccessSci5463 (TM) - POWERWAND 4FRr x 8cm, Safety Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL 5Fr x 10cm, Introducer with Extended Dwell Catheter Protech3048 (TM) - Falcon Protech3048 (TM) - Awl Protech3048 (TM) - Lightning Merit1383 (TM) - Universal Coaxial Needles Irras9981 (TM) - Hummingbird Quad Irras9981 (TM) - Hummingbird Solo Zeiss34518 (TM) - Z Cartridge IOL Delivery System SurgicalSpecialties6945 (TM) - Barbed Mono Sutures PFMMedical6614 (TM) - ASEPT Peritoneal Catheter Kit (Ref 622284) PFMMedical6614 (TM) - ASEPT Peritoneal Drainage System (Ref M7008) 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 Kurin7497 (TM) - Kurin Blood Culture Collection Set Martech9038 (TM) - NON CORING HUBER NEEDLE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-08-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-08-16
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2020-03-07
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2018-04-19
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2022-04-24
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
KNZ Accessories, A-V Shunt Gastroenterology, Urology Class 2 876.5540 2020-01-13
KXE Prosthesis, Wrist, Hemi-, Ulnar Orthopedic Class 2 888.3810 2024-08-12
MER Stent, Urethral, Prostatic, Permanent Or Semi-Permanent Unknown Class 3 N/A 2026-03-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-08
EZL Catheter, Retention Type, Balloon Gastroenterology, Urology Class 2 876.5130 2019-12-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-08
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2015-12-28
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
MEB Pump, Infusion, Elastomeric General Hospital Class 2 880.5725 2022-04-24
QRB Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy Unknown Class 3 N/A 2024-08-26
LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown Class 3 N/A 2024-08-26
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-12-08
OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Unknown Class 3 N/A 2024-08-26
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2024-08-26
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-12-28
DRC Trocar Cardiovascular Class 2 870.1390 2024-10-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-12-27
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2024-11-04
KDQ Bottle, Collection, Vacuum General Hospital Class 2 880.6740 2012-12-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-07
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-09
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-11-24
JCY Catheter, Infusion General, Plastic Surgery Class 1 878.4200 2020-01-13
PPN Percutaneous Catheter, Ultrasound Cardiovascular Class 2 870.1250 2025-12-02
GCZ Retainer, Surgical General, Plastic Surgery Class 1 878.4800 2023-04-20
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2015-09-03
HTW Bit, Drill Orthopedic Class 1 888.4540 2022-12-22
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2022-12-22
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-12-22
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2020-01-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2024-10-15
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2022-12-26
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-01-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-01-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
LFK Catheter, Femoral Gastroenterology, Urology Class 2 876.5540 2020-01-13
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2020-01-13
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-01-06
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2026-01-06
EXF Bag, Bile Collecting Gastroenterology, Urology Class 2 876.5010 2017-11-08
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-03-07
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2015-09-02
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2025-09-16
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-08
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2026-01-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-01-13
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2020-04-30
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2012-11-01
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2012-11-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2024-08-12
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2022-04-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-24
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2024-10-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-08
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-12-17
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-10-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-07-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-02-09
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-02-09
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2012-12-18
FME Gown, Examination General Hospital Class 1 880.6265 2020-01-13
LXC Monitor, Pressure, Intracompartmental Unknown Class U N/A 2024-01-03
OEQ Angiography/Angioplasty Kit Cardiovascular Class 2 870.1650 2013-01-28
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2012-12-27
LXC Monitor, Pressure, Intracompartmental Unknown Class U N/A 2024-01-03
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2026-01-05
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2025-12-09
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-07-05
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2012-11-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-07-05
MUU System, Suction, Lipoplasty General, Plastic Surgery Class 2 878.5040 2020-11-18
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2024-10-15
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2020-12-15
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2022-06-30
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-06-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-06-30
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2020-04-30
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-16
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 2024-08-21
PZP Fluid Jet Removal System General, Plastic Surgery Class 2 876.4350 2025-02-17
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2020-01-13
DRB Stylet, Catheter Cardiovascular Class 2 870.1380 2024-08-12
LFK Catheter, Femoral Gastroenterology, Urology Class 2 876.5540 2020-01-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2020-01-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-12-13
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-12-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-12-13
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2024-08-13
PTI Non-Coring (Huber) Needle General Hospital Class 2 880.5570 2020-01-13
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2020-01-13
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2023-05-19
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-05-19
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered General, Plastic Surgery Class 1 878.4680 2023-04-20
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
OJA Intravenous Extension Tubing Set General Hospital Class 2 880.5440 2018-09-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-07-05
GAD Retractor General, Plastic Surgery Class 1 878.4800 2020-11-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-12-27
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2019-11-21
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2015-11-11
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2024-11-04
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2020-03-07
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2026-01-05
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2020-03-07
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2022-12-22
PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access Cardiovascular Class 2 870.1252 2020-01-31
NWV Laparoscopic Accessories, Gynecologic Obstetrics/Gynecology Class 1 884.1720 2014-06-20
PZK Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) Ophthalmic Class 3 886.3600 2018-12-20
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2020-12-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-01-08
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2024-11-04
LPO Gases Used Within Eye To Place Pressure On Detached Retina Ophthalmic Class 3 886.4270 2025-11-25
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2020-03-07
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
PPD Universal Drainage Tray Gastroenterology, Urology Class 2 876.5130 2020-03-20
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2020-11-16
QPY Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation Unknown Class 3 N/A 2024-08-27
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-10-24
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2025-07-31
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2018-09-24
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2024-08-16
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-08-16
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-08-16
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2024-08-16
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2020-01-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
PND Midline Catheter General Hospital Class 2 880.5200 2020-03-11
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-03-09
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
DQA Oximeter Cardiovascular Class 2 870.2700 2012-12-28
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2020-01-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2026-01-05
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-12-27
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic Ophthalmic Class 2 886.1385 2019-06-07
MZY Graft, Vascular, Stainless Steel Tunneler Cardiovascular Class 2 870.3450 2020-01-13
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2024-10-18
PZP Fluid Jet Removal System General, Plastic Surgery Class 2 876.4350 2023-12-04
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-07-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-16
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-12-08
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-11
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2025-01-03
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-12-28
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-24
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
MUU System, Suction, Lipoplasty General, Plastic Surgery Class 2 878.5040 2020-12-15
EYJ Holder, Ureteral Catheter Gastroenterology, Urology Class 1 876.5130 2020-11-16
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2014-03-03
KNZ Accessories, A-V Shunt Gastroenterology, Urology Class 2 876.5540 2020-01-13
MCM Implant, Cochlear Unknown Class 3 N/A 2024-08-27
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2020-01-13
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2013-01-17
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-07
QWM Stent Graft, Bypass, Superficial Femoral Artery Unknown Class 3 N/A 2025-11-21
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-06-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-06-06
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2024-06-06
NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed General, Plastic Surgery Class 2 878.4400 2023-04-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-12-26
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2022-12-26
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2022-12-26
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 2022-12-26
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2022-12-26
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2024-08-27
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2024-08-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-09-10
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-12-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-08-16
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-07
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-07
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-09-11
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-24
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2019-06-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-03-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-11-04
HOC Clip, Iris Retractor Ophthalmic Class 1 886.4350 2012-12-28
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-03-07
LFJ Catheter, Subclavian Gastroenterology, Urology Class 2 876.5540 2020-01-13
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2012-11-01
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-05-02
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2024-09-16
BSO Catheter, Conduction, Anesthetic Anesthesiology Class 2 868.5120 2024-09-16
MNB Device, Thermal Ablation, Endometrial Unknown Class 3 N/A 2023-04-19
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2022-04-24
LZU Plug, Punctum Unknown Class U N/A 2022-12-26
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown Class 3 N/A 2024-08-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-10-15
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2024-08-16
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-24
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
LZU Plug, Punctum Unknown Class U N/A 2022-12-26
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-03-07
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2018-10-24
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-11
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 2024-08-16
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2024-10-24
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-12-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-07
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-10-24
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2020-01-13
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2019-11-21
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-03-07
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-03-08
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-02-24
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2019-06-07
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2012-11-01
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2020-01-13
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-08-12
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2023-04-05
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2026-01-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-11-04
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-03-09
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2013-01-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-13
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2013-01-07
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-27
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2026-01-06
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-11-21
LWR Heart-Valve, Non-Allograft Tissue Unknown Class 3 N/A 2021-02-02
FTD Lamp, Surgical General, Plastic Surgery Class 2 878.4580 2020-10-22
OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption General, Plastic Surgery Class 2 878.4590 2023-03-21
KRG Programmer, Pacemaker Cardiovascular Class 3 870.3700 2024-08-27
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2022-12-26
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2024-08-21
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-10-15
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2026-01-05
EGJ Device, Iontophoresis, Other Uses Physical Medicine Class 2 890.5525 2024-08-16
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-02-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-12-28
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2022-12-26
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-11
PYB Minor Surgical Procedures Tray General, Plastic Surgery Class 1 878.4800 2020-03-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-21
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-10-31
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-03-24
OFC Catheter Introducer Kit Cardiovascular Class 2 870.1340 2013-01-28
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-12-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-09-24
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2024-10-15
OMT Absorbable Lung Biopsy Plug General, Plastic Surgery Class 2 878.4755 2024-04-01
LXC Monitor, Pressure, Intracompartmental Unknown Class U N/A 2024-01-03
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2026-03-13
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2023-05-15
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2020-03-07
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-04-19
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2022-04-19
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2020-01-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-01-06
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2026-01-06
MEB Pump, Infusion, Elastomeric General Hospital Class 2 880.5725 2022-04-24
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-11-24
LFK Catheter, Femoral Gastroenterology, Urology Class 2 876.5540 2020-03-09
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2024-08-27
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2024-08-27
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2020-03-09
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2019-11-21
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2023-04-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2015-08-20
QQH Powered Insertion System For A Cochlear Implant Electrode Array Ear, Nose, Throat Class 2 874.4450 2022-10-20
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-12-08
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2022-12-26
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2012-11-16
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-07
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2024-08-12
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2026-01-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-03-09
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2026-01-05
JXG Shunt, Central Nervous System And Components Neurology Class 2 882.5550 2023-01-24
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2023-01-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-07-05
MHW Dressing, Compression General Hospital Class 1 880.5075 2020-09-10
BZT Stethoscope, Esophageal, With Electrical Conductors Anesthesiology Class 2 868.1920 2020-11-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-08-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-02-27
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2025-02-27
PPJ Peritoneal Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5630 2020-03-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-08-21
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2020-01-13
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2012-12-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-01-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-03-08
LXC Monitor, Pressure, Intracompartmental Unknown Class U N/A 2024-01-03
DWM Apparatus, Suction, Patient Care Cardiovascular Class 2 870.5050 2020-03-11
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-09-25
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2015-09-02
MEB Pump, Infusion, Elastomeric General Hospital Class 2 880.5725 2022-04-24
KGS Retention Device, Suture General, Plastic Surgery Class 1 878.4930 2018-04-27
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2022-01-07
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-13
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2025-01-17
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2012-12-27
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2020-12-15
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2025-02-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-11-04
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-04-20
GDF Guide, Needle, Surgical General, Plastic Surgery Class 1 878.4800 2012-12-28
GWM Device, Monitoring, Intracranial Pressure Neurology Class 2 882.1620 2023-01-24
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2020-01-13
PND Midline Catheter General Hospital Class 2 880.5200 2020-01-13
MSS Folders And Injectors, Intraocular Lens (Iol) Ophthalmic Class 1 886.4300 2023-04-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-01-13
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2022-12-26
PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered Ophthalmic Class 2 886.4100 2023-01-21
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2024-09-23
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-12-28
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2020-01-13
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-12-30
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2019-12-30
PTI Non-Coring (Huber) Needle General Hospital Class 2 880.5570 2020-01-13
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2019-06-07

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
K221518 Np Medical NP Medical nCompass Extension Set with Stabilizing Base 2022-11-03
K953474 Medikmark, Inc. IV START KIT 1995-10-02
K972493 Nipro Medical Corp. NIPRO DISPOSABLE SOLUTION INFUSION SET 1997-09-18
K982672 Baxter Healthcare Corp COLLEAGUE PUMP SYRINGE ADAPTER SET 1998-09-04
K143446 Roche Diagnostics GmbH Accu-Chek FlexLink Plus infusion set 2015-08-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
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CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025 Smiths Medical ASD Inc. 2
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013 Baxter Healthcare Corp. Rt. 2
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030624. Last updated year: 2026. Please use registration number 2030624 when referencing this establishment in official correspondence.
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