Isomedix Operations Inc.

FDA Device Registration & Listing · S Plainfield, NJ, US · Registration 2246552

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
2246552
FEI Number
2246552
Entity Name
Isomedix Operations Inc.
City/State/Country
S Plainfield, NJ, US
Establishment Address
3459 SOUTH CLINTON AVE., S Plainfield, NJ 07080, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 9072619)
Owner / Operator Contact Address
5960 Heisley Road, --, 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

Peregrine3901 (PL) - Membrane Scraper Peregrine3901 (PL) - Tapered Diffusion Illuminator Peregrine3901 (PL) - Endoilluminator MicrolineSurgical3881 (PL) - Disposable ReNew Forceps MicrolineSurgical3881 (PL) - ReNew Forceps MicrolineSurgical3881 (PL) - Electrosurgical Cautery Probes MicrolineSurgical3881 (PL) - ReNew Laparoscopic Instruments Globus4330 (PL) - PROVIDENT Peregrine3901 (PL) - Powered laser surgical instrument Navilyst5285 (PL) - Mini Stick ENVI LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD Singles Pledgeted Striped LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD 6-Tray LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD Singles Pledgeted Green LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD Singles Striped LSISol6612 (PL) - RAM COR-SUTURE QUICK LOAD Singles Pledgeted White US_Endoscopy4223 (PL) - AquaShield System CO2 FUJIFILM US_Endoscopy4223 (PL) - AquaShield System CO2 US_Endoscopy4223(PL) - AquaShield System- PENTAX US_Endoscopy4223 (PL) - AquaShield System- CO2 PENTAX US_Endoscopy4223 (PL) - Irrigation Kit Standard US_Endoscopy4223 (PL) - Irrigation Kit CO2 Long US_Endoscopy4223 (PL) - BioGuard air/water & suction valves-Olympus (4 pc kit) US_Endoscopy4223 (PL) - BioGuard air/water & suction valves-Olympus (3 pc kit) US_Endoscopy4223 (PL) - Irrigation Kit CO2 Short US_Endoscopy4223 (PL) - Endoscopic Tip Protector US_Endoscopy4223 (PL) - Articulator injection needle - enteroscope US_Endoscopy4223 (PL) - Carr-Locke injection needle US_Endoscopy4223 (PL) - Articulator injection needle Peregrine3901 (PL) - Instrument, manual, Surgical, General Use Hobbs3950 (PL) - Microbiology Brush Peregrine3901 (PL) - Keratome, battery-powered Navilyst5285 (PL) - BioFlo Midline Peregrine3901 (PL) - Photocagulator and accessories Insulet5490 (NR) - Omnipod 5 Automated Insulin Delivery System LSISol6612 (PL) - PNEUMOSTOP PLUS Device LSISol6612 (PL) - PNEUMOSTOP Device Zimmer (PL) - ZIMMER SEGMENTAL SYSTEM B&L1665 (PL) - PMMA Anterior Chamber Intraocular Lens TerumoMed3380 (PL) - Radifocus Introducer II TerumoMed3380 (PL) - Radifocus Introducer II with R/O Marker L&Z7835 (PL) - CATHTONGTM II PICC Catheter TerumoMed3380 (PL) - Glidesheath Slender LSISol6612 (PL) - RD QUICK LOAD SUTURE – 2-0 MONOGLIDE LSISol6612 (PL) - RD QUICK LOAD SUTURE – 2-0 STRONGSORB LSISol6612 (PL) - RD QUICK LOAD SUTURE – 0 Polyester LSISol6612 (PL) - RD QUICK LOAD SUTURE – 0 MONOGLIDE US_Endoscopy4223 (PL) - BioShield Biopsy Valve LSISol6612 (PL) - FS-35 FS DEVICES LSISol6612 (PL) - Combo Box of 6 FORNISEE Devices - 2 each of FS-30, FS-35, FS-40 LSISol6612 (PL) - FS-40 FS DEVICES LSISol6612 (PL) - FS-30 FS DEVICES DORC10527 (PL) - Phacoemulsification / Vitrectomy System DORC10527 (PL) - Vitrectomy System DORC10527 (PL) - Phacoemulsification / Vitrectomy System / Ophthalmic Laser MicrolineSurgical3881 (PL) - ReNew Forceps MicrolineSurgical (PL) - ReNew Disposable Scissor Tip MicrolineSurgical3881 (PL) - ReNew Laparoscopic Instruments MicrolineSurgical3881 (PL) - ReNew Metzenbaum Scissor Tip, Disposable MicrolineSurgical3881 (PL) - ReNew Microscissor Tip, Disposable MicrolineSurgical3881 (PL) -ReNew Mini Endocut Scissor Tip, Disposable MicrolineSurgical3881 (PL) -ReNew Endocut Scissor Tip, Disposable MicrolineSurgical3881 (PL) - Electrosurgical Cautery Probes MicrolineSurgical3881 (PL) - Disposable ReNew Forceps MicrolineSurgical3881 (PL) - ReNew Hook Scissor Tip, Disposable MicrolineSurgical3881 (PL) -ReNew Delicate Metzenbaum Scissor Tip, Disposable Navilyst5285 (PL) - Xcela US_Endoscopy4223 (PL) - Padlock Clip Defect Closure System US_Endoscopy4223 (PL) - Padlock Clip Pro-Select Defect Closure System Zimmer (PL) - Persona Revision Knee System Navilyst5285 (PL) - Xcela Navilyst5285 (PL) - BioFlo Hobbs3950 (PL) - Looped Retriever Navilyst5285 (PL) - Mini Stick Max Cornidus5713 (PL) - System, Catheter Control, Steerable Peregrine3901 (PL) - Powered laser surgical instrument Zimmer (PL) - ROSA® Knee System TerumoMed3380 (PL) - Femoseal JamesAlex4786 (PL) - Mastisol blister Italian version (bilk-packed) JamesAlex4786 (PL) -Mastisol blister (bulk-packed) JamesAlex4786 (PL) - Detachol blister UK version JamesAlex4786 (PL) - Mastisol blister UK version JamesAlex4786 (PL) - Detachol blister Italian version JamesAlex4786 (PL) - Detachol blister US_Endoscopy4223 (PL) - Histolock Resection Device TerumoMed3380 (PL) - Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal guide Navilyst5285 (PL) - SmartPort+ and SmartPort Plastic LSISol6612 (PL) - RD – THE RUNNING DEVICE BARIATRIC LENGTH LSISol6612 (PL) - RD – THE RUNNING DEVICE Zimmer (PL) - ROSA Knee System US_Endoscopy4223 (PL) - BioShield Biopsy Valve EUS Insulet5490 (PL) - Omnipod 5 Automated Insulin Delivery System US_Endoscopy4223 (PL) - Talon Grasping Device TerumoMed3380 (PL) - MedAmicus Coaxial Introducer TerumoMed3380 (PL) - Pinnacle R/O II Introducer Kit Navilyst5285 (PL) - Xcela Navilyst5285 (PL) - BioFlo US_Endoscopy4223 (PL) - Torrent irrigation scope connector - Pentax US_Endoscopy4223 (PL) - Torrent irrigation tubing Peregrine3901 (PL) - Device, irrigation, ocular surgery Globus4330 (PL) - PROVEN Gen-Flex Peregrine3901 (PL) - Keratome (Microkeratome) Blade Viant8257 (PL) - Raphael 25L NisshaMedical (PL) - Copilot Q TerumoMed3380 (PL) - Manan GWI Guide Wire Introducer Peregrine3901 (PL) - Powered laser surgical instrument L&Z7835 (PL) - CATHTONGTM II PICC Catheter Hobbs3950 (PL) - Scope Introducer TriceMedical7859 (PL) - mi-eye 2 MicrolineSurgical3881 (PL) - ReNew Laparoscopic Instruments MicrolineSurgical3881 (PL) - Electrosurgical Cautery Probes MicrolineSurgical3881 (PL) - ReNew Straight Cautery Probe Tip, Disposable MicrolineSurgical3881 (PL) - ReNew L-Hook Cautery Probe Tip, Disposable MicrolineSurgical3881 (PL) - Disposable ReNew Forceps MicrolineSurgical3881 (PL) - ReNew Spatula Cautery Probe Tip, Disposable MicrolineSurgical3881 (PL) - ReNew J-Hook Cautery Probe Tip, Disposable MicrolineSurgical3881 (PL) - ReNew Forceps Thermedx7581 (PL) - Luer Lock Set, Single Lumen Thermedx7581 (PL) - Urology Set Thermedx7581 (PL) - Tubing Set - Single Lumen, Inflow with Dual Outflow Zimmer (PL) - Persona Revision Knee System TerumoMed3380 (PL) - Pinnacle Introducer Sheath, Radifocus Introducer II LSISol6612 - LS-5 ePTFE Suture US_Endoscopy4223 (PL) - Coin Tip Snare US_Endoscopy4223 (PL) - Lariat Snare Peregrine3901 (PL) - Keratome, battery-powered Intera9479 (PL) - Non-Coring (Huber) Needle - Intera 3000 Refill Kit TerumoMed3380 (PL) - Pinnacle R/O II, Radifocus Introducer II with R/O Marker US_Endoscopy4223 (PL) - Infinity Cytology Brush US_Endoscopy4223 (PL) - Histoguide wire-guided forceps Globus4330 (PL) - Concord Bone Cement Navilyst5285 (PL) - Xcela Navilyst5285 (PL) - BioFlo Midline Navilyst5285 (PL) -BioFlo PICC Hobbs3950 (PL) - Transbronchial Aspiration Needle Hobbs3950 (PL) - superDimension Aspirating Needle Peregrine3901 (PL) - Powered laser surgical instrument US_Endoscopy4223 (PL) - BioGuard valves & air/water cleaning adapter kit (00711785) US_Endoscopy4223 (PL) - BioGuard valves (3-pc) & air/water cleaning adapter kit (00711786) Insulet5490 (PL) - Omnipod DASH Insulin Management System Insulet5490 (PL) - OmniPod Insulin Management System Peregrine3901 (PL) - Cannula, ophthalmic J&J2483 (GP) - Band-Aid Intera9479 (PL) - Accessories for Model 3000 Series Implantable Infusion Pump Hobbs3950 (PL) - Mistifier Spray Catheter Endogator Spray Catheter Globus4330 (PL) - Kinex Medivators2752 (PL) - Defendo Fujifilm 700 series valve kits LSISol6612 (PL) - COR-SUTURE QUICK LOAD - 2-0 Polyester, White, Non-Absorbable LSISol6612 (PL) - COR-KNOT QUICK LOAD 6-POUCH LSISol6612 (PL) - C1 Depth Limiter LSISol6612 (PL) - COR-KNOT QUICK LOAD SINGLES LSISol6612 (PL) - C1 Device LSISol6612 (PL) - COR-KNOT MINI COMBO KIT LSISol6612 (PL) - COR-KNOT MIS COMBO KIT LSISol6612 (PL) - RD QUICK LOAD SUTURE – 2-0 Polypropylene LSISol6612 (PL) - C1 Device (Straight Shaft) LSISol6612 (PL) - RD180 10mm – THE RUNNING DEVICE LSISol6612 (PL) - TK Ti-KNOT DEVICE LSISol6612 (PL) - COR-KNOT MIS DEVICE KIT LSISol6612 (PL)- RD QUICK LOAD SUTURE – 2-0 Polyester LSISol6612 (PL) - RD180 SP – THE RUNNING DEVICE LSISol6612 (PL)- COR-SUTURE QUICK LOAD - 3-0 Polypropylene, Non-Absorbable LSISol6612 (PL) - INTRA-KNOT QUICK LOAD LSISol6612 (PL) - COR-KNOT MINI DEVICE KIT LSISol6612 (PL) - COR-SUTURE QUICK LOAD - 2-0 Polyester, Green, Non-Absorbable LSISol6612 (PL) - RD180 5mm – THE RUNNING DEVICE LSISol6612 (PL)- TK QUICK LOAD Peregrine3901 (PL) - Endoilluminator StrykerSustainability6623 (SDA) - Electrode Cable Innovative7777 (SDA) - CABLE, ELECTRODE L&Z7835 (PL) - CATHTONG I PICC Catheter Navilyst5285 (PL) - PASV MS KIT Peregrine3901 (PL) - Powered laser surgical instrument WellsLamont8889 (PL) - Cut Resistant Surgical Glove Liners Hobbs3950 (PL) - Freeman Pancreatic Flexi-Stent - Straight Hobbs3950 (PL) - Pusher Catheter Hobbs3950 (PL) - Freeman Pancreatic Flexi-Stent - Single Pigtail Hobbs3950 (PL) - Guide Catheter Globus4330 (PL) - GenFlex2 Navilyst5285 (PL) - Xcela US_Endoscopy4223 (PL) - Moray micro forceps TerumoMed3380 (PL) - Pinnacle R/O II HiFlo MicrolineSurgical3881 (PL) - M/L-10 Clip Cartridge, 19 Clips, Disposable MicrolineSurgical3881 (PL) - M/L-10 Clip Cartridge, 8 Clips, Disposable MicrolineSurgical3881 (PL) - M/L-10 Clip Cartridge, 10 Clips, Disposable MicrolineSurgical3881 (PL) - Clip / Scissor Procedure Kit, M/L-10 Cartridge 19 Clips (1), Endocut Scissor Tip (1) US_Endoscopy4223 (PL) - Articulator Injection Needle; Carr-Locke Injection Needle Peregrine3901 (PL) - Device, irrigation, ocular surgery DORC10527 (PL) - device, irrigation, ocular surgery US_Endoscopy4223 (PL) - Roth Net Retrieval Devices- Foreign Body Universal US_Endoscopy4223 (PL) - Roth Net Retrieval Devices-  Foreign Body Standard US_Endoscopy4223 (PL) - Roth Net Retrieval Devices-Foreign Body Maxi Navilyst5285 (PL) - Exodus Nuance Navilyst5285 (PL) - Exodus Believe Navilyst5285 (PL) - Exodus Array US_Endoscopy4223 (PL) - Torrent Irrigation Tubing LSISol6612 (PL) - Aortic Root Retractor, Medium LSISol6612 (PL) - SEW-EASY Cassette Singles, 5mm LSISol6612 (PL) - 3D MINI ACESS PORTAL LSISol6612 (PL) - RAM PACK LSISol6612 (PL) - SEW-EASY COMBO Kit, 5mm LSISol6612 (PL) - Aortic Root Retractor, Large LSISol6612 (PL) - MINI-RUMEL LSISol6612 (PL) - SEW-EASY M Device LSISol6612 (PL) - RAM Device LSISol6612(PL) - RAM RING LSISol6612 (PL) - SEW-EASY Device Kit LSISol6612 (PL) - Aortic Root Retractor, Small LSISol6612 (PL) - SEW-EASY SNARE LSISol6612 (PL) - SEW-EASY Cassettes LSISol6612 (PL) - SEW-EASY Device Kit, 5mm LSISol6612(PL) - SEW EASY Combo Kit LSISol6612(PL) - RAM Device 5mm Peregrine3901 (PL) - Catheter, continuous flush Conformis6082 (PL) - Kinos Globus4330 (PL) - BIOLOX DELTA Peregrine3901 (PL) - Laser, ophthalmic, Peregrine3901 (PL) - Aspirating Laser Probe, Ophthalmic DORC10527 (PL) - endoilluminator Globus4330 (PL) - GenFlex2 TerumoMed3380 (PL) - R2P Destination Slender Guiding Sheath US_Endoscopy4223 (PL) - Infinity ERCP sampling device Lacey2530 (PL) - BES NIM NAV PAK NEEDLE TROCAR TerumoMed3380 (PL) - TR Band; TR BAND Radial Compression Device Peregrine3901 (PL) - Laser, ophthalmic, Hobbs3950 (PL) - Ureteral Double Pigtail Stent Hobbs3950 (PL) - Biliary Pigtail Stents US_Endoscopy4223 (PL) - AquaShield system Peregrine3901 (PL) - Shilded Diffusion Illuminator Peregrine3901 (PL) - Keratome, battery-powered Globus4330 (PL) - PROVIDENT US_Endoscopy4223 (PL) - Exacto cold snare US_Endoscopy4223 (PL) - iSnare system-Lariat Snare TerumoMed3380 (PL) - TR Band; TR BAND Radial Compression Device Peregrine3901 (PL) - Catheter, continuous flush US_Endoscopy4223 (PL) - Traxtion hexagonal snare US_Endoscopy4223 (PL) - Rotator - snare - mini-oval US_Endoscopy4223 (PL) - Short Throw - snare - enteroscope US_Endoscopy4223 (PL) - Short Throw - snare - mini-oval US_Endoscopy4223 (PL) - Rotator - snare - oval US_Endoscopy4223 (PL) - Short Throw - snare - oval L&Z7835 (PL) - CATHTONGTM III Tapered PICC Catheter TerumoMed3380 (PL) - Glidesheath Adhezion5351 (PL) - Surgiseal Stylus

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2012-11-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-05
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2012-12-17
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-08-23
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-08-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-08-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-08-23
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2023-08-23
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2023-08-23
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2023-08-23
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2023-08-23
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-03-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-09-30
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2012-12-17
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2012-11-05
GBX Catheter, Irrigation General, Plastic Surgery Class 1 878.4200 2023-07-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-07-07
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2018-02-20
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2018-02-20
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2020-01-09
PRT Gastric Irrigation And Aspiration Kit Gastroenterology, Urology Class 2 876.5980 2020-01-09
OCU Endoscopic Storage Cover Gastroenterology, Urology Class 2 876.1500 2020-02-08
GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief) Neurology Class 2 882.5870 2024-04-12
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2023-05-30
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2018-08-31
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-12-20
BSY Catheters, Suction, Tracheobronchial Anesthesiology Class 1 868.6810 2012-11-06
OPP Pump, Infusion, Insulin Bolus General Hospital Class 2 880.5725 2024-09-18
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2023-04-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-12-17
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2012-12-27
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2024-09-04
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2012-11-05
EME Punch, Biopsy, Surgical Dental Class 1 872.4565 2012-12-20
HMY Keratome, Battery-Powered Ophthalmic Class 1 886.4370 2015-05-04
NZP Sealant, Microbial General, Plastic Surgery Class 2 878.4370 2018-02-08
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2017-05-11
HQB Photocoagulator And Accessories Ophthalmic Class 2 886.4690 2015-05-04
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2012-11-05
GXZ Electrode, Needle Neurology Class 2 882.1350 2023-06-21
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2015-06-04
ORD Optical Coherence Tomography, Intravascular Catheter Cardiovascular Class 2 870.1200 2015-06-04
QFG Alternate Controller Enabled Insulin Infusion Pump Clinical Chemistry Class 2 880.5730 2024-09-05
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2020-03-09
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-12-04
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2014-11-13
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-02-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-02-08
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2022-02-08
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-01-05
OOG Knee Arthroplasty Implantation System Orthopedic Class 2 888.3560 2022-01-05
MPN Tissue Adhesive For The Topical Approximation Of Skin General, Plastic Surgery Class 2 878.4010 2018-02-08
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2012-12-17
HXD Clamp General, Plastic Surgery Class 1 878.4800 2015-05-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-10-16
HDR Cap, Cervical Obstetrics/Gynecology Class 2 884.5250 2012-12-17
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2024-01-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-05-17
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2020-12-28
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-12-28
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2012-11-05
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2015-03-03
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2015-03-03
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2015-03-03
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2015-03-03
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2022-01-05
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2022-01-05
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2014-06-16
HEW Culdoscope (And Accessories) Obstetrics/Gynecology Class 2 884.1640 2014-06-16
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-02-19
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2025-02-19
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2025-02-19
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2025-02-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-05
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2017-04-17
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2020-04-30
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2022-05-27
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2022-05-27
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-05-27
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-11-25
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2024-09-18
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2012-12-17
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2022-11-01
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2022-11-01
NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene General, Plastic Surgery Class 2 878.5035 2022-11-01
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2012-11-05
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2014-11-04
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2014-04-08
DXX System, Catheter Control, Steerable Cardiovascular Class 2 870.1290 2022-10-19
GXZ Electrode, Needle Neurology Class 2 882.1350 2023-06-21
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2024-01-23
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2012-12-17
MQH Microtools, Assisted Reproduction (Pipettes) Obstetrics/Gynecology Class 2 884.6130 2012-12-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-03-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-11-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-06-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-12-14
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2025-12-02
KOX Solvent, Adhesive Tape General, Plastic Surgery Class 1 878.4730 2015-04-07
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2020-12-14
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2023-06-02
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2023-06-02
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2026-03-19
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2018-08-31
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2021-12-20
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2012-12-17
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2019-09-27
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2020-05-26
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2015-03-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2015-03-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2020-01-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-02-19
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2022-01-05
GXZ Electrode, Needle Neurology Class 2 882.1350 2023-06-21
QJI Interoperable Automated Glycemic Controller Clinical Chemistry Class 2 862.1356 2024-09-05
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2012-11-05
BZT Stethoscope, Esophageal, With Electrical Conductors Anesthesiology Class 2 868.1920 2023-06-12
ORQ Mesh, Surgical, Deployer General, Plastic Surgery Class 2 878.3300 2023-10-25
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2023-10-25
FGO Dislodger, Stone, Flexible Gastroenterology, Urology Class 2 876.4680 2018-08-31
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2020-12-04
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-12-04
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2020-12-04
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-12-04
KWH Prosthesis, Toe, Constrained, Polymer Orthopedic Class 2 888.3720 2022-11-01
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-11-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-11-06
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2017-05-11
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2012-12-17
HGI Electrocautery, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.4120 2012-12-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-09-30
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2018-08-31
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2012-12-17
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2020-03-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-05-05
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2025-05-05
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-08-23
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2020-12-18
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-07-07
HMY Keratome, Battery-Powered Ophthalmic Class 1 886.4370 2015-05-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2025-11-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-01-23
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2012-12-17
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2022-01-05
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2026-02-11
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2021-12-20
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2023-06-21
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-03-11
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2024-01-10
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2025-11-24
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2012-12-17
FGY Cannula, Injection General, Plastic Surgery Class 1 878.4200 2023-04-27
HRX Arthroscope Orthopedic Class 2 888.1100 2023-09-19
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2015-11-10
HHT Spatula, Cervical, Cytological Obstetrics/Gynecology Class 2 884.4530 2012-12-17
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2012-11-05
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2015-11-10
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2023-04-27
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2023-06-30
FMF Syringe, Piston General Hospital Class 2 880.5860 2023-06-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-05
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2020-01-03
HRX Arthroscope Orthopedic Class 2 888.1100 2020-01-03
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2020-01-03
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2021-01-05
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-01-05
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2021-01-05
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2025-05-05
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-05-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-11-06
NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene General, Plastic Surgery Class 2 878.5035 2018-02-20
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2020-05-08
LZB Finger Cot General Hospital Class 1 880.6250 2023-06-15
HMY Keratome, Battery-Powered Ophthalmic Class 1 886.4370 2015-05-04
PTI Non-Coring (Huber) Needle General Hospital Class 2 880.5570 2023-05-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-11-06
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2018-08-31
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-06-15
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2018-08-31
MFD Cannula, Intrauterine Insemination Obstetrics/Gynecology Class 2 884.5250 2012-12-17
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-11-22
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2017-05-11
PND Midline Catheter General Hospital Class 2 880.5200 2017-05-11
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2012-11-05
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2024-04-16
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-12-04
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2015-11-10
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2012-11-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-11-05
NWU Endoscope Introducer Kit Gastroenterology, Urology Class 2 876.1500 2018-09-02
LZG Pump, Infusion, Insulin General Hospital Class 2 880.5725 2024-09-05
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2015-11-10
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2020-03-10
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-01-05
OOG Knee Arthroplasty Implantation System Orthopedic Class 2 888.3560 2022-01-05
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2022-01-05
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2012-12-20
LKK Pump, Infusion, Implanted, Programmable Unknown Class 3 N/A 2024-10-18
KWH Prosthesis, Toe, Constrained, Polymer Orthopedic Class 2 888.3720 2022-11-01
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered General, Plastic Surgery Class 2 878.4780 2026-04-01
KNW Instrument, Biopsy Gastroenterology, Urology Class 2 876.1075 2023-07-07
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2020-03-09
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2012-11-05
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2012-10-26
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2012-10-26
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-03-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2017-11-22
FDF Colonoscope And Accessories, Flexible/Rigid 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
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2025-01-08
KNA Instrument, Manual, Specialized Obstetric-Gynecologic Obstetrics/Gynecology Class 2 884.4530 2012-12-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-06-16
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2014-06-16
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2014-06-16
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 2014-06-16
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2024-10-15
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2023-05-31
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2017-08-23
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2023-04-27
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2012-11-05
HGE Amniotome Obstetrics/Gynecology Class 1 884.4530 2012-12-27
HFE Brush, Endometrial Obstetrics/Gynecology Class 2 884.1100 2012-12-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-03-10
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-01-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-01-08
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-08
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-11-05
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2012-12-17
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2012-12-20
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2012-11-05
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-08-23
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2023-08-23
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular General Hospital Class 2 880.5965 2014-03-24
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2012-11-05
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2018-08-31
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-11-06
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-11-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-11-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2022-01-04
HFC Aspirator, Endocervical Obstetrics/Gynecology Class 2 884.1050 2012-12-17
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-11-24
KYG Device, Irrigation, Ocular Surgery Ophthalmic Class 1 886.4360 2012-12-20
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2018-08-31
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2018-08-31
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-01-10
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2012-11-05
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2018-08-31
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2012-12-27
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-11-19
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2020-11-19
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2024-09-04
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2023-08-23
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2023-08-23
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2023-08-23
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2023-08-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2023-08-23
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2023-08-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2023-08-23
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2023-08-23
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2023-06-02
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2023-06-02
HQN Conformer, Ophthalmic Ophthalmic Class 2 886.3130 2024-01-23
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered Ophthalmic Class 2 886.4150 2012-11-05
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2012-11-05
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2020-12-14
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2025-02-19
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2023-10-25
OWY Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery Class 2 878.3300 2023-10-25
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-08-23
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2023-08-23
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-05-17
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2018-08-31
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-10-12
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2019-10-12
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2014-04-08
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2023-01-10
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2020-03-10
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2012-12-17
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-11-01
HDB Extractor, Vacuum, Fetal Obstetrics/Gynecology Class 2 884.4340 2014-04-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2014-04-07
NPL Barrier, Animal Source, Intraoral Dental Class 2 872.3930 2012-12-28
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2023-06-09
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2012-11-05
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2020-10-30
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2018-08-31
MPA Endoilluminator Gastroenterology, Urology Class 2 876.1500 2012-11-05
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2015-05-29
HMY Keratome, Battery-Powered Ophthalmic Class 1 886.4370 2015-05-04
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2012-12-17
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2012-12-20
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2021-12-27
OOG Knee Arthroplasty Implantation System Orthopedic Class 2 888.3560 2021-12-27
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2021-12-27
HQB Photocoagulator And Accessories Ophthalmic Class 2 886.4690 2015-05-04
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2023-08-23
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2023-08-23
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2018-08-31
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2018-08-31
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2018-08-31
PZP Fluid Jet Removal System General, Plastic Surgery Class 2 876.4350 2023-12-04
MQF Catheter, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6110 2012-12-17
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2012-12-27
PCF Sampler, Endocervical Obstetrics/Gynecology Class 2 884.1050 2014-04-08
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2012-12-27
BYY Tube, Aspirating, Flexible, Connecting General Hospital Class 2 880.6740 2012-11-06
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2018-05-17
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2021-11-04
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2021-11-04
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 2014-04-08
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2014-04-08
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2024-04-16
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2018-08-31
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2020-12-14
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days General Hospital Class 2 880.5970 2024-01-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2018-05-17
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-06-15
GXZ Electrode, Needle Neurology Class 2 882.1350 2023-06-21
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2015-11-10
MRH Pump, Infusion, Ophthalmic General Hospital Class 2 880.5725 2012-11-05
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2015-06-04
NQQ System, Imaging, Optical Coherence Tomography (Oct) Radiology Class 2 892.1560 2015-06-04
MPN Tissue Adhesive For The Topical Approximation Of Skin General, Plastic Surgery Class 2 878.4010 2012-10-11

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

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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
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The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2246552. Last updated year: 2026. Please use registration number 2246552 when referencing this establishment in official correspondence.
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