Synergy Health Ireland Ltd

FDA Device Registration & Listing · Tullamore Offaly, IE · Registration 3002807314

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
3002807314
FEI Number
3002807314
Entity Name
Synergy Health Ireland Ltd
City/State/Country
Tullamore Offaly, IE
Establishment Address
IDA Business and Technology Park, Tullamore Offaly R35 X865, IE
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
STERIS Corporation (Owner Number: 10042227)
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

Harmac2308 (TL) - Avance Solo NPWT System LakeRegion8374 (TH,TL) - Lake Region Axessio Stryker10080 (TL) - Exeter X3 RimFit Cup Zimmer (WP) - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS Creagh8289 (TL) - First Choice Creagh8289 (TL) - Advance Serenity™ 18 Hollister (BT) - Vapro Plus Hollister (BT) - Vapro Plus Pocket Hollister (TL) - VaPro Pocket Zimmer (TL) - PERSONA® Revision Knee System Molnlycke (KK,VL) - Lyofoam Max FirstWater14138 (RG) - DUP86266-9 - Xtrasorb Foam Adhesive Molnlycke (KK,VL) - Lyofoam Dressings FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive AdvMed8429 (BF) - "McKesson Calcium Alginate Dressing FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive StrykerIreland (TL) - 12cm iQ Micro StrykerIreland (TL) - 12cm iQ Barracuda StrykerIreland (TL) - 18cm iQ Apex Micro Claw StrykerIreland (TL) - 12cm iQ Micro Claw StrykerIreland (TL) - 12cm iQ Claw StrykerIreland (TL) - 12cm iQ 120 Claw StrykerIreland (TL) - 20cm iQ Standard StrykerIreland (TL) - 12cm iQ Apex 360 StrykerIreland (TL) - 20cm iQ Apex 360 StrykerIreland (TL) - 11cm iQ Apex Knife StrykerIreland (TL) - 12cm iQ Large StrykerIreland (TL) -10cm iQ Broad Knife StrykerIreland (TL) - 11cm iQ Knife StrykerIreland (TL) - 12cm iQ Serrated Large StrykerIreland (TL) - 18cm iQ Micro Claw StrykerIreland (TL) - 12cm iQ Standard Crega6530 (TH) - GORE® DrySeal Flex Introducer Sheath Zimmer (TL) - Persona Vit E Poly Articular Blocks (MC) Edwards10187 (TL) - PASCAL Precision Transcatheter Valve Repair System Creagh8289 (TL) - Sublime Microcatheter Summit8301 (DV) - HiVac7 Bone Cement Mixing and Delivery System (Triple application) C703 Summit8301 (DV) - HiVac7 with Femoral Cement Pressuriser CP701 Summit8301 (DV) - 9mm Nozzle with Nozzle Extruder Escoffier11264 (MC) - DISPENSER, CEMENT Creagh8289 (TL) - Sublime™ 014 Rx PTA Balloon Dilatation Catheter Zimmer (TL) - PERSONA® Revision Knee System Creagh8289 (TL) - Biotronik Passeo-35 HP Creagh8289 (TL) - First Choice StrykerIreland (TL) - 37cm iQ Large Arrotek8349 (TL) - LiquID 061 Guide Catheter Extension BSCI (KK,TL) - SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System BSCI (KK,TL) - SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System BSCI (KK,TL) - SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System Neuravi11842 (TL) - EMBOTRAP III Revascularization Device Medtronic8444 (TL) - Symplicity Spyral™ Renal Denervation System Edwards10187 (TL) - Edwards Commander Delivery System Zimmer (TL,DK) - Persona TM Porous Natural Tibia, Vivacit -E Patella and Articular Surfaces Stryker10080 (TL) - Exeter X3 RimFit Cup Neuravi11842 (TL) - EMBOTRAP III Revascularization Device BSCI (TL) - Ranger Perfuze (VL) - Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Teleflex (TL) - Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set Edwards10187 (TL) - Edwards Commander Delivery System BSCI (TL) - SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Cable BSCI (TL) - POLARx FIT Cryoablation Balloon Catheter [Short Tip (ST)] POLARx FIT Cryoablation Balloon Catheter [Long Tip BSCI (TL) - POLARx Cryoablation Balloon Catheter [Short Tip (ST)] POLARx Cryoablation Balloon Catheter [Long Tip (LT)] AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PACAT0 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PXCAT0 AutonoMeTM Automated Pre- loaded Delivery System (CCATT3-T6) AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CNAET0 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CCAET3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System PACAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre-loaded Delivery System PXYAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre-loaded Delivery System PAYAT3-T6 AlconLabs9477 (TL,TH) - AutonoMe Automated Pre- loaded Delivery System CCAET0 Arrotek8349 (TL) - LiquID 51 LP Guide Catheter Extension Creagh8289 (TL) - Advance Serenity™ 14 Zimmer (WP) - Continuum And Trilogy Integrated Taper (IT) Acetabular Systems

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRX Arthroscope Orthopedic Class 2 888.1100 2013-03-22
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2026-01-30
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-05
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2023-04-26
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2024-12-11
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2020-06-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-31
BTS Tube, Bronchial (W/Wo Connector) Anesthesiology Class 2 868.5720 2013-03-06
MQR Stent, Colonic, Metallic, Expandable General, Plastic Surgery Class 2 878.3610 2013-01-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2013-01-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-10-22
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2017-07-19
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2015-10-23
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-01-06
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2019-09-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-03-07
KNH Laparoscopic Contraceptive Tubal Occlusion Device Obstetrics/Gynecology Class 3 884.5380 2018-11-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-01-30
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-01-30
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2022-11-03
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2022-11-03
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-11-03
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-11-03
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-01-31
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-06
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-09-08
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-12-30
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-09-15
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2013-03-04
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2014-12-15
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2025-05-12
MAF Stent, Coronary Unknown Class 3 N/A 2013-03-05
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2020-03-02
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2020-03-02
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2020-03-02
HRX Arthroscope Orthopedic Class 2 888.1100 2013-03-22
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2015-10-23
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2013-03-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2013-03-06
PCU Pancreatic Stent, Covered, Metallic, Removable Gastroenterology, Urology Class 2 876.5015 2017-06-08
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2017-06-08
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2020-12-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-10-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-07-21
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2020-01-15
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2013-03-06
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-03-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-06
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2019-06-19
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2020-06-18
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems Clinical Chemistry Class 2 862.1355 2020-06-18
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2018-01-01
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2026-01-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-01
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2024-04-08
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-04-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2024-04-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2024-04-08
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2024-04-08
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2024-04-08
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2024-04-08
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2024-04-08
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2013-03-06
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-11-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-30
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-04-29
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2016-07-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-05
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2025-11-20
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2015-05-15
EZD Catheter, Straight Gastroenterology, Urology Class 2 876.5130 2024-05-24
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-03-11
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2022-03-11
MUM Stent, Metallic, Expandable, Duodenal General, Plastic Surgery Class 2 878.3610 2017-12-03
MQR Stent, Colonic, Metallic, Expandable General, Plastic Surgery Class 2 878.3610 2017-12-03
OJK Eye Tray Ophthalmic Class 2 886.4790 2025-12-01
PLJ Tissue Adhesive Internal Use General, Plastic Surgery Class 3 878.4010 2023-06-28
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2013-01-31
FIB Protector, Transducer, Dialysis Gastroenterology, Urology Class 2 876.5820 2014-12-16
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-09-15
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2013-02-15
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2013-01-31
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-07-21
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2012-12-20
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-10-23
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-01-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2013-01-31
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2013-03-06
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2013-03-06
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2016-11-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2015-08-25
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-12-23
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-03-03
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2013-03-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-12-15
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2015-10-23
PTL Wire, Guide, Catheter, Exempt Cardiovascular Class 2 870.1330 2025-05-12
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-05-14
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-03-11
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2024-08-15
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2015-02-27
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-12-08
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2025-07-21
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2017-08-04
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-08-04
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2017-08-04
POE Extended Depth Of Focus Intraocular Lens Ophthalmic Class 3 886.3600 2013-03-01
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2013-03-01
MFK Lens, Multifocal Intraocular Ophthalmic Class 3 886.3600 2013-03-01
MJP Lens, Intraocular, Toric Optics Ophthalmic Class 3 886.3600 2013-03-01
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2014-12-15
LOD Bone Cement Orthopedic Class 2 888.3027 2019-09-18
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-09-18
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-02-03
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2016-10-31
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-12-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-06-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-18
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2013-01-31
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2015-09-16
OJG Neurological Tray Neurology Class 1 882.4525 2025-12-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-01-24
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-05-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2019-11-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-05-25
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-01
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2019-04-25
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-01-31
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2026-01-30
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2013-03-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-10-22
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2026-04-03
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-12-23
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2026-03-02
NIM Stent, Carotid Unknown Class 3 N/A 2012-12-20
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-01-30
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-12-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-12-11
NKM Mitral Valve Repair Devices Unknown Class 3 N/A 2023-06-14
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2023-05-23
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2013-03-06
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2013-01-30
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2025-07-21
FCS Light, Catheter, Fiberoptic, Glass, Ureteral Gastroenterology, Urology Class 2 876.4020 2025-07-21
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-01-30
NIO Stent, Iliac Unknown Class 3 N/A 2016-01-13
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-12-11
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2024-12-11
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2016-10-26
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2013-03-11
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2026-03-02
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2017-05-19
OTD Endovascular Suturing System Cardiovascular Class 2 870.3460 2024-07-12
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-01-30
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2013-03-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-05-12
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2013-01-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2012-11-27
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-01-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-30
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2013-01-31
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2018-09-26
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-01-02
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2013-08-02
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-29
MAF Stent, Coronary Unknown Class 3 N/A 2013-03-11
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2018-07-18
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2014-12-15
FPB Filter, Infusion Line General Hospital Class 2 880.5440 2020-12-10
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2023-05-17
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-05-17
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2014-07-29
BTR Tube, Tracheal (W/Wo Connector) Anesthesiology Class 2 868.5730 2013-03-06
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2013-01-17
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2016-01-11
MTJ Wax, Bone Unknown Class U N/A 2019-03-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2014-12-15
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2013-01-03
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2024-12-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-12-11
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2020-05-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-05-31
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-01-01
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2018-01-01
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-05-17
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2015-02-27
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-11-11
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2013-01-29
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2013-03-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-02-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-03-30
OEQ Angiography/Angioplasty Kit Cardiovascular Class 2 870.1650 2019-09-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-01
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2018-04-25
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2019-04-11
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-31
GFD Dermatome General, Plastic Surgery Class 1 878.4820 2014-01-13
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2013-06-12
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2013-01-31
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2026-03-31
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2015-10-22
LOD Bone Cement Orthopedic Class 2 888.3027 2013-02-15
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2013-03-06
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2013-03-18
OKV Obstetrical Kit Obstetrics/Gynecology Class 2 884.4520 2020-11-30
LJE Catheter, Nephrostomy Unknown Class U N/A 2013-03-22
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2013-03-22
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2013-03-22
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2013-03-22
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-22
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2013-03-22
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2013-03-22
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2017-11-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-11-15
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2013-01-29
LJE Catheter, Nephrostomy Unknown Class U N/A 2013-01-29
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-01-29
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2013-01-29
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-29
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2022-03-11
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-03-11
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2022-03-11
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-12-23
LJE Catheter, Nephrostomy Unknown Class U N/A 2013-01-30
MUM Stent, Metallic, Expandable, Duodenal General, Plastic Surgery Class 2 878.3610 2013-01-30
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-19
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2013-03-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-12-21
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-03-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-31
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-12-23
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-30
EYA Stylet, Ureteral Gastroenterology, Urology Class 1 876.5130 2013-12-30
PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated Unknown Class 3 N/A 2017-10-04
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2013-01-31
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2014-08-15
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2018-01-05
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2024-03-05
PRL Iliac Covered Stent, Arterial Unknown Class 3 N/A 2017-04-25
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2023-11-08
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-07-23
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2017-01-16
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2018-01-19
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2013-03-06
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2022-02-09
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2024-08-15
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2026-01-30
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2022-12-26
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2015-09-01
BSN Filter, Conduction, Anesthetic Anesthesiology Class 2 868.5130 2013-03-07
NIO Stent, Iliac Unknown Class 3 N/A 2014-07-09
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2024-09-04
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-12-23
JOH Tube Tracheostomy And Tube Cuff Anesthesiology Class 2 868.5800 2013-03-06
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2013-01-31
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2025-12-23
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-12-23
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-01-29
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-03-04
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2013-03-06
GXP Methyl Methacrylate For Cranioplasty Neurology Class 2 882.5300 2013-02-14
KOH Instrument, Manual, General Obstetric-Gynecologic Obstetrics/Gynecology Class 1 884.4520 2013-05-03
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2013-03-06
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2013-03-06
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-12-15
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2016-02-19
MQR Stent, Colonic, Metallic, Expandable General, Plastic Surgery Class 2 878.3610 2013-01-29
MUM Stent, Metallic, Expandable, Duodenal General, Plastic Surgery Class 2 878.3610 2013-01-29
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-03-11
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2018-01-19
QYI Ablation Catheter, Renal Denervation Unknown Class 3 N/A 2024-04-29
NPV Pulmonary Valve Prosthesis Percutaneously Delivered Unknown Class f N/A 2023-11-27
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2019-04-11
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2013-03-05
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2013-03-05
NIO Stent, Iliac Unknown Class 3 N/A 2013-03-05
PNB Biliary Stent System For Benign Strictures Gastroenterology, Urology Class 2 876.5011 2016-07-20
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-01-30
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2021-06-03
NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry Class 2 862.1345 2025-09-22
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2025-09-22
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2023-12-12
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2013-12-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-10-16
BSN Filter, Conduction, Anesthetic Anesthesiology Class 2 868.5130 2020-12-11
PNO Catheter, Percutaneous, Cutting/Scoring Cardiovascular Class 2 870.1250 2012-12-20
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2017-08-04
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2017-08-04
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-08-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-01-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-10-23
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-11-03
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2022-11-03
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-11-03
JDG Prosthesis, Hip, Femoral Component, Cemented, Metal Orthopedic Class 2 888.3360 2022-11-03
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2013-01-31
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2017-03-20
LNR System, Photopheresis, Extracorporeal Unknown Class 3 N/A 2018-03-12
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2025-12-15
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2026-01-30
PNJ Leadless Pacemaker Cardiovascular Class 3 870.3610 2026-01-30
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2016-06-01
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2019-09-18
HRX Arthroscope Orthopedic Class 2 888.1100 2019-09-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-01-30
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2013-01-30
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-03-22
ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown Class 3 N/A 2021-01-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-01-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-01
FEG Tube, Double Lumen For Intestinal Decompression And/Or Intubation Gastroenterology, Urology Class 2 876.5980 2026-04-03
OMP Negative Pressure Wound Therapy Powered Suction Pump General, Plastic Surgery Class 2 878.4780 2022-10-17
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2013-01-31
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2016-11-16
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2015-10-23
MAF Stent, Coronary Unknown Class 3 N/A 2012-12-20
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2012-12-20
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2012-12-20
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-12-20
NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Unknown Class 3 N/A 2012-12-20
NIN Stent, Renal Unknown Class 3 N/A 2012-12-20
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2018-07-18
MAF Stent, Coronary Unknown Class 3 N/A 2018-07-18
NIV Coronary Covered Stent Unknown Class f N/A 2018-07-18
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2013-12-30
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2013-06-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-01
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-05-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-31
MPN Tissue Adhesive For The Topical Approximation Of Skin General, Plastic Surgery Class 2 878.4010 2015-08-26
NRY Catheter, Thrombus Retriever Cardiovascular Class 2 870.1250 2024-02-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-10-23
NPU Prosthesis, Mitral Valve, Percutaneously Delivered Unknown Class 3 N/A 2023-11-27
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2023-11-27
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2017-08-11
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-12-30
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2023-08-15
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-30
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2019-06-21
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2013-03-05
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-29
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2014-12-15
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2017-02-27
OOY Bronchial Thermoplasty System Unknown Class 3 N/A 2013-12-06
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2014-12-10
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-22
HQL Intraocular Lens Ophthalmic Class 3 886.3600 2021-02-05
MFK Lens, Multifocal Intraocular Ophthalmic Class 3 886.3600 2021-02-05
POE Extended Depth Of Focus Intraocular Lens Ophthalmic Class 3 886.3600 2021-02-05
MJP Lens, Intraocular, Toric Optics Ophthalmic Class 3 886.3600 2021-02-05
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2014-12-10
MAF Stent, Coronary Unknown Class 3 N/A 2013-01-31
MIR Shunt, Portosystemic, Endoprosthesis Unknown Class 3 N/A 2013-01-31
NIO Stent, Iliac Unknown Class 3 N/A 2013-01-31
NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection Cardiovascular Class 2 870.1250 2023-11-08
NGV System, Appendage Closure, Left Atrial Unknown Class 3 N/A 2019-04-01
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-12-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2019-02-21
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2019-02-21
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2019-02-21
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2013-03-18
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-03-12
EYB Catheter, Ureteral, Gastro-Urology Gastroenterology, Urology Class 2 876.5130 2013-03-22
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2018-05-29
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2015-05-15
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece Ear, Nose, Throat Class 2 874.4250 2015-05-15
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2013-07-16
BSN Filter, Conduction, Anesthetic Anesthesiology Class 2 868.5130 2013-02-12
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2015-09-04
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2019-10-16
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-07-31
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2014-12-10
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2024-12-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-09-20
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2023-05-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-03-06
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-09-19
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2014-11-11
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2016-02-12
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2016-02-12
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-30
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-31
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-10-23
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2013-12-31
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2013-03-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2020-11-23
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-12-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2024-12-11
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2018-07-05
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-07-05
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2018-07-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-10-28

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

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
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K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K902734 Olympus Corp. PR CANNULAS 1990-08-22
K232458 ABBOTT MEDICAL JETi™Hydrodynamic Thrombectomy System 2023-12-19
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Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011 Navilyst Medical, Inc 2
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807314. Last updated year: 2026. Please use registration number 3002807314 when referencing this establishment in official correspondence.
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