FDA Device Registration & Listing · Coventry, RI, US · Registration 1000121056
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2023-08-29 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2020-08-05 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2022-03-14 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2015-11-25 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2008-08-07 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-22 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2014-11-10 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2019-04-23 |
| PCU | Pancreatic Stent, Covered, Metallic, Removable | Gastroenterology, Urology | Class 2 | 876.5015 | 2019-04-23 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2013-12-16 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2018-10-08 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2022-03-21 |
| FGX | Snare, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2014-02-05 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2014-02-05 |
| MCX | Catheter, Coronary, Atherectomy | Unknown | Class 3 | N/A | 2008-01-22 |
| LPB | Cardiac Ablation Percutaneous Catheter | Unknown | Class 3 | N/A | 2008-01-14 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-10 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2017-08-14 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-22 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-02 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | Unknown | Class 3 | N/A | 2010-10-28 |
| NVY | Permanent Defibrillator Electrodes | Unknown | Class 3 | N/A | 2010-10-28 |
| NIQ | Coronary Drug-Eluting Stent | Unknown | Class 3 | N/A | 2015-10-05 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2016-03-24 |
| KTI | Bronchoscope Accessory | Ear, Nose, Throat | Class 2 | 874.4680 | 2017-06-30 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-10 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2008-01-22 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2008-01-14 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2023-06-20 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-09-09 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2020-01-23 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2020-01-23 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | General, Plastic Surgery | Class 2 | 878.3300 | 2023-07-15 |
| OFK | Percutaneous Atrial Catheter Kit | Cardiovascular | Class 2 | 870.1250 | 2024-08-07 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2014-10-29 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2014-04-22 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2017-01-26 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2017-01-26 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2017-01-26 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2017-01-26 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2014-09-05 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2012-03-09 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-03-09 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-22 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2008-01-03 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2013-12-16 |
| NWT | Endoscopic Cholangiogram Kit | Gastroenterology, Urology | Class 2 | 876.1500 | 2013-08-12 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2014-10-29 |
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | Class 2 | 870.5150 | 2014-10-29 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-05-12 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2016-05-12 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4290 | 2016-12-15 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-22 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-01-20 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2023-01-20 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2024-03-19 |
| MAV | Syringe, Balloon Inflation | Cardiovascular | Class 2 | 870.1650 | 2008-01-03 |
| MIR | Shunt, Portosystemic, Endoprosthesis | Unknown | Class 3 | N/A | 2008-01-22 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-02-09 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2023-07-13 |
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | Class 2 | 870.5150 | 2014-10-29 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2014-10-29 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2022-02-03 |
| QEY | Mechanical Thrombolysis Catheter | Cardiovascular | Class 2 | 870.5150 | 2022-02-03 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2000-05-18 |
| MAF | Stent, Coronary | Unknown | Class 3 | N/A | 2000-05-18 |
| NIQ | Coronary Drug-Eluting Stent | Unknown | Class 3 | N/A | 2000-05-18 |
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | Unknown | Class 3 | N/A | 2000-05-18 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2000-05-18 |
| NIN | Stent, Renal | Unknown | Class 3 | N/A | 2000-05-18 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2020-10-19 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2020-10-19 |
| LQR | Dislodger, Stone, Biliary | Gastroenterology, Urology | Class 2 | 876.5010 | 2020-02-05 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | Class 2 | 870.2900 | 2013-12-16 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-10 |
| FFY | Adaptor, Bulbs, Miscellaneous, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2005-08-10 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2022-03-14 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2014-10-21 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2022-04-12 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2015-12-22 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2024-06-03 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Cardiovascular | Class 2 | 870.1250 | 2024-10-14 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2017-09-16 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | Gastroenterology, Urology | Class 2 | 876.4680 | 1992-07-22 |
| MAV | Syringe, Balloon Inflation | Cardiovascular | Class 2 | 870.1650 | 2014-09-26 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2021-05-04 |
| NIO | Stent, Iliac | Unknown | Class 3 | N/A | 2012-12-13 |
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-12-11 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2023-08-03 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2022-09-09 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Unknown | Class 3 | N/A | 2008-01-14 |
| LPB | Cardiac Ablation Percutaneous Catheter | Unknown | Class 3 | N/A | 2008-01-14 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2020-09-17 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-03-26 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2014-03-10 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2023-06-28 |
| NIO | Stent, Iliac | Unknown | Class 3 | N/A | 2008-01-22 |
| MAF | Stent, Coronary | Unknown | Class 3 | N/A | 2008-01-22 |
| MIR | Shunt, Portosystemic, Endoprosthesis | Unknown | Class 3 | N/A | 2008-01-22 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2022-03-14 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2008-01-14 |
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | Class 2 | 870.5150 | 2014-10-29 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2014-10-29 |
| NIQ | Coronary Drug-Eluting Stent | Unknown | Class 3 | N/A | 2011-11-28 |
| JCT | Prosthesis, Tracheal, Expandable | General, Plastic Surgery | Class 2 | 878.3720 | 2014-10-21 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2019-03-12 |
| KQT | Evacuator, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.4370 | 2003-04-24 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2026-05-21 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2012-09-24 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2015-06-28 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-11-14 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2017-11-14 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2011-12-12 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2011-12-12 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2013-11-20 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2010-09-09 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2023-06-28 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2011-12-13 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2017-01-26 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2014-10-29 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2012-12-13 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2014-06-16 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2014-07-25 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | Class 2 | 876.4400 | 2025-05-30 |
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male | General, Plastic Surgery | Class 2 | 878.3300 | 2022-03-10 |
| LQR | Dislodger, Stone, Biliary | Gastroenterology, Urology | Class 2 | 876.5010 | 2018-05-31 |
| QEY | Mechanical Thrombolysis Catheter | Cardiovascular | Class 2 | 870.5150 | 2019-10-11 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2019-10-11 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2011-07-27 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2014-09-19 |
| KNQ | Dilator, Esophageal | Gastroenterology, Urology | Class 2 | 876.5365 | 2016-12-05 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | Class 2 | 876.5980 | 2016-07-21 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2025-08-28 |
| MQR | Stent, Colonic, Metallic, Expandable | General, Plastic Surgery | Class 2 | 878.3610 | 2025-12-02 |
| MUM | Stent, Metallic, Expandable, Duodenal | General, Plastic Surgery | Class 2 | 878.3610 | 2025-12-02 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | General, Plastic Surgery | Class 2 | 878.3300 | 2008-12-11 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-01-03 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-06-24 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2004-09-13 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2016-05-20 |
| FGX | Snare, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-05-20 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2008-01-10 |
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-05-27 |
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | Class 1 | 878.4160 | 2020-05-27 |
| NTN | Led Light Source | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-05-27 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2008-01-03 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2008-01-03 |
| FFA | Tube, Drainage, Suprapubic | Gastroenterology, Urology | Class 2 | 876.5090 | 2008-01-03 |
| LJE | Catheter, Nephrostomy | Unknown | Class U | N/A | 2008-01-03 |
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-31 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2008-01-14 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-10 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2014-04-24 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2014-04-24 |
| KNQ | Dilator, Esophageal | Gastroenterology, Urology | Class 2 | 876.5365 | 2014-04-24 |
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | Obstetrics/Gynecology | Class 2 | 884.4910 | 2021-12-16 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2010-03-25 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2010-03-25 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | General, Plastic Surgery | Class 2 | 878.3300 | 2008-01-03 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2026-01-06 |
| LJE | Catheter, Nephrostomy | Unknown | Class U | N/A | 2026-01-06 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2017-05-18 |
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-12-22 |
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | Unknown | Class 3 | N/A | 2024-01-31 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2017-04-04 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2013-01-23 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2016-08-24 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2006-09-14 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2025-08-21 |
| EZN | Dilator, Catheter, Ureteral | Gastroenterology, Urology | Class 2 | 876.5470 | 2008-01-03 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-12-22 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-12-23 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2016-12-23 |
| LZC | Medical Glove, Specialty | General Hospital | Class 1 | 880.6250 | 2008-01-03 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | Class 2 | 870.1310 | 2022-03-14 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2022-03-14 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2022-03-14 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | General, Plastic Surgery | Class 2 | 878.3300 | 2013-03-17 |
| GBM | Catheter, Urethral | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-03 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2022-03-14 |
| KOE | Dilator, Urethral | Gastroenterology, Urology | Class 2 | 876.5520 | 2013-09-06 |
| EZN | Dilator, Catheter, Ureteral | Gastroenterology, Urology | Class 2 | 876.5470 | 2013-09-06 |
| DXO | Transducer, Pressure, Catheter Tip | Cardiovascular | Class 2 | 870.2870 | 2020-03-30 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | Class 2 | 870.1310 | 2024-01-09 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-11-14 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-22 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2008-01-03 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2021-09-27 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | Class 2 | 876.4400 | 2022-08-30 |
| FGX | Snare, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2020-10-21 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2020-10-21 |
| NIO | Stent, Iliac | Unknown | Class 3 | N/A | 2012-12-13 |
| KTI | Bronchoscope Accessory | Ear, Nose, Throat | Class 2 | 874.4680 | 2008-01-14 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2008-01-30 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2008-01-14 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2017-03-27 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2024-11-25 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2008-01-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2008-01-10 |
| FDX | Endoscopic Cytology Brush | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-01-14 |
| FFA | Tube, Drainage, Suprapubic | Gastroenterology, Urology | Class 2 | 876.5090 | 2008-01-03 |
| LJE | Catheter, Nephrostomy | Unknown | Class U | N/A | 2008-01-03 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2008-01-03 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2008-01-03 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-09-21 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2019-03-13 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-22 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | Class 2 | 870.1310 | 2022-03-14 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2024-11-13 |
| LQC | Lithotriptor, Biliary Mechanical | Gastroenterology, Urology | Class 2 | 876.4500 | 2016-12-05 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | General, Plastic Surgery | Class 2 | 878.3300 | 2012-12-11 |
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | Class 2 | 876.1500 | 2021-05-26 |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-05-31 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2024-03-25 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2021-09-01 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2016-07-27 |
| OCW | Endoscopic Tissue Approximation Device | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-05-03 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | General, Plastic Surgery | Class 2 | 878.3300 | 2007-05-10 |
| GCB | Needle, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 1983-09-09 |
| QEY | Mechanical Thrombolysis Catheter | Cardiovascular | Class 2 | 870.5150 | 2022-04-26 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2022-04-26 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2014-09-05 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2022-06-30 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2015-10-15 |
| NIP | Stent, Superficial Femoral Artery | Unknown | Class 3 | N/A | 2011-04-25 |
| FGX | Snare, Non-Electrical | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-05-24 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2015-03-31 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | Class 2 | 876.1500 | 2013-06-04 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2012-09-20 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | Class 2 | 876.4400 | 2023-05-03 |
| OCW | Endoscopic Tissue Approximation Device | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-05-03 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2010-09-15 |
| OHD | Gynecological Laparoscopic Kit | Obstetrics/Gynecology | Class 2 | 884.1720 | 2013-07-02 |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-01-14 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2011-12-09 |
| MCX | Catheter, Coronary, Atherectomy | Unknown | Class 3 | N/A | 2014-10-29 |
| PNB | Biliary Stent System For Benign Strictures | Gastroenterology, Urology | Class 2 | 876.5011 | 2026-02-18 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2026-02-18 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2016-12-20 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2020-03-30 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2012-05-08 |
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | Class 2 | 870.5150 | 2014-10-29 |
| NIP | Stent, Superficial Femoral Artery | Unknown | Class 3 | N/A | 2015-08-05 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2011-01-06 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2016-02-16 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2008-01-03 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2011-12-12 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2010-12-07 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-06 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2017-02-06 |
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | Unknown | Class 3 | N/A | 2020-11-02 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2016-08-25 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2025-08-28 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2014-01-07 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2014-01-07 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2008-01-14 |
| QTD | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss | Gastroenterology, Urology | Class 2 | 876.5983 | 2023-05-03 |
| QTD | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss | Gastroenterology, Urology | Class 2 | 876.5983 | 2023-10-16 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2008-01-14 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2012-12-11 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2012-08-22 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-05-01 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2025-01-24 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2017-03-29 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2013-11-13 |
| FAE | Prosthesis, Penile | Gastroenterology, Urology | Class 2 | 876.3630 | 2019-04-19 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2008-01-03 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2024-02-05 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2020-12-04 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2020-12-04 |
| FQH | Lavage, Jet | General Hospital | Class 2 | 880.5475 | 2020-12-04 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2023-12-12 |
| OCW | Endoscopic Tissue Approximation Device | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-08-22 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2003-04-18 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2025-05-08 |
| FFA | Tube, Drainage, Suprapubic | Gastroenterology, Urology | Class 2 | 876.5090 | 2025-05-08 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2021-05-03 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | Cardiovascular | Class 2 | 870.2900 | 2022-03-14 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2022-05-17 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2024-12-17 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Gastroenterology, Urology | Class 2 | 876.5010 | 2022-05-12 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | Class 2 | 870.1310 | 2024-08-14 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2008-01-22 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2008-01-22 |
| EZB | Stylet For Catheter, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.5130 | 2002-01-15 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2006-08-22 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 1992-07-22 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2011-10-25 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2008-01-14 |
| JCT | Prosthesis, Tracheal, Expandable | General, Plastic Surgery | Class 2 | 878.3720 | 2016-05-31 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2013-07-18 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2022-03-21 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2011-12-05 |
| NIU | Stent, Superficial Femoral Artery, Drug-Eluting | Unknown | Class 3 | N/A | 2018-09-24 |
| LQR | Dislodger, Stone, Biliary | Gastroenterology, Urology | Class 2 | 876.5010 | 2021-06-02 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2018-05-11 |
| NIN | Stent, Renal | Unknown | Class 3 | N/A | 2008-12-23 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2008-01-11 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 1992-08-27 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2008-01-11 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-01-14 |
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | Class 1 | 878.4200 | 2008-01-14 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2014-02-05 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2008-01-14 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2015-10-13 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2015-10-13 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Unknown | Class 3 | N/A | 2023-08-10 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2012-01-06 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | Class 2 | 876.4400 | 2023-01-30 |
| IWP | Radiographic Protective Glove | Radiology | Class 1 | 892.6500 | 1992-07-22 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2023-09-30 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2014-02-18 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2012-09-20 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2022-07-19 |
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Unknown | Class 3 | N/A | 2016-02-25 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Unknown | Class 3 | N/A | 2016-02-25 |
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-01-14 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-01-14 |
| NJE | Intracranial Neurovascular Stent | Unknown | Class f | N/A | 2008-01-10 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2014-08-06 |
| PWI | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse | Obstetrics/Gynecology | Class 2 | 884.4910 | 2018-03-09 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2009-12-07 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2015-10-06 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2013-10-28 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2008-01-11 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Cardiovascular | Class 2 | 870.5100 | 2022-03-29 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4290 | 2017-11-14 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2017-11-14 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3025434462 | Obsidio Inc | Maple Grove, MN, US |
| 3005619880 | Boston Scientific Corporation | Roswell, GA, US |
| 3015425075 | NALU MEDICAL | Carlsbad, CA, US |
| 3015289131 | FARAPULSE, INC. | Menlo Park, CA, US |
| 3022298579 | Boston Scientific Cardiac Diagnostic Technologies, Inc. | Arden Hills, MN, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K172288 | Wilson-Cook Medical Inc./Cook Endoscopy | Fusion OMNI Sphincterotome | 2018-04-17 |
| K792141 | Pharmaseal Div., Baxter Healthcare Corp. | CONTINUOUS FLUSH DEVICE | 1979-12-05 |
| K924661 | Baxter Healthcare Corp | SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER | 1993-04-08 |
| K101883 | St Jude Medical | 6F ENGAGE/ENGAGE TR INTRODUCER | 2010-09-07 |
| K034025 | Nmt Medical, Inc. | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC | 2004-03-26 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter |
| Z-0010-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter |
| Z-0011-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter |
| Z-0012-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter |
| Z-0013-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013526170 | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | Changzhou Jiangsu, CN |
| 3002807310 | Synergy Health Sterilisation UK Ltd | Berkshire Reading, GB |
| 1320894 | CONMED CORPORATION | Utica, NY, US |
| 3014769442 | Aomori Olympus Co., Ltd. Hirosaki Site | Hirosaki-shi Aomori, JP |
| 3002806337 | Akita Sumitomo Bakelite Co., Ltd. | Akita, JP |
1000121056 when referencing this establishment in official correspondence.