FDA Device Registration & Listing · ERIE, PA, US · Registration 2528981
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2025-12-15 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| FTD | Lamp, Surgical | General, Plastic Surgery | Class 2 | 878.4580 | 2025-12-15 |
| KNW | Instrument, Biopsy | Gastroenterology, Urology | Class 2 | 876.1075 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| GZL | Electrode, Depth | Neurology | Class 2 | 882.1330 | 2025-12-15 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Cardiovascular | Class 2 | 870.4360 | 2025-12-15 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2025-12-15 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2025-12-15 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4350 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2025-12-15 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3350 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-12-15 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2025-12-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | Class 2 | 870.1310 | 2025-12-15 |
| FGO | Dislodger, Stone, Flexible | Gastroenterology, Urology | Class 2 | 876.4680 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| FPB | Filter, Infusion Line | General Hospital | Class 2 | 880.5440 | 2025-12-15 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2025-12-15 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2025-12-15 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | General, Plastic Surgery | Class 2 | 878.5000 | 2025-12-15 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2025-12-15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-15 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2025-12-15 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Orthopedic | Class 2 | 888.3150 | 2025-12-15 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2025-12-15 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2025-12-15 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2025-12-15 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3350 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2025-12-15 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2025-12-15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-15 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | General, Plastic Surgery | Class 2 | 878.4400 | 2025-12-15 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-15 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2025-12-15 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-15 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2025-12-15 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-15 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | General, Plastic Surgery | Class 2 | 878.5000 | 2025-12-15 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| GZL | Electrode, Depth | Neurology | Class 2 | 882.1330 | 2025-12-15 |
| PDU | Catheter For Crossing Total Occlusions | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| FQH | Lavage, Jet | General Hospital | Class 2 | 880.5475 | 2025-12-15 |
| FPD | Tube, Feeding | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2025-12-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2025-12-15 |
| FTL | Mesh, Surgical, Polymeric | General, Plastic Surgery | Class 2 | 878.3300 | 2025-12-15 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2026-04-30 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-12-15 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | Class 1 | 878.4680 | 2025-12-15 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2025-12-15 |
| HEW | Culdoscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1640 | 2025-12-15 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2026-04-30 |
| KOB | Catheter, Suprapubic (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5090 | 2026-04-30 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | Cardiovascular | Class 2 | 870.4360 | 2025-12-15 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2025-12-15 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | Hematology | Class 2 | 864.9205 | 2025-12-15 |
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | Class 2 | 880.5725 | 2025-12-15 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-12-15 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2025-12-15 |
| OZD | Temporary Non-Roller Type Left Heart Support Blood Pump | Unknown | Class 3 | N/A | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| MSD | Catheter, Hemodialysis, Implanted | Gastroenterology, Urology | Class 2 | 876.5540 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2025-12-15 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2025-12-15 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3650 | 2025-12-15 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2025-12-15 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3670 | 2025-12-15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| NEZ | System, Imaging, Gastrointestinal, Wireless, Capsule | Gastroenterology, Urology | Class 2 | 876.1300 | 2025-12-15 |
| GZL | Electrode, Depth | Neurology | Class 2 | 882.1330 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2025-12-15 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2025-12-15 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3510 | 2025-12-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3540 | 2025-12-15 |
| OZT | Balloon Aortic Valvuloplasty | Cardiovascular | Class 2 | 870.1255 | 2025-12-15 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-15 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-15 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2025-12-15 |
| NVM | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-12-15 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-15 |
| OMZ | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| NJL | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | Unknown | Class 3 | N/A | 2025-12-15 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| PNF | Aortic Stent | Unknown | Class 3 | N/A | 2025-12-15 |
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | Class 2 | 880.5725 | 2025-12-15 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2025-12-15 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2025-12-15 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-15 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2025-12-15 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | Orthopedic | Class 2 | 888.3150 | 2025-12-15 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2026-04-30 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2025-12-15 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2025-12-15 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2025-12-15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2025-12-15 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | General, Plastic Surgery | Class 2 | 878.4400 | 2025-12-15 |
| FEO | Lithotriptor, Ultrasonic | Gastroenterology, Urology | Class 2 | 876.4480 | 2025-12-15 |
| NPV | Pulmonary Valve Prosthesis Percutaneously Delivered | Unknown | Class f | N/A | 2025-12-15 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery | Class 3 | 878.4490 | 2025-12-15 |
| PMX | Absorbable Collagen Hemostatic Agent With Thrombin | General, Plastic Surgery | Class 3 | 878.4490 | 2025-12-15 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2025-12-15 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| EXD | Irrigator, Ostomy | Gastroenterology, Urology | Class 2 | 876.5895 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2025-12-15 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2025-12-15 |
| OMZ | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2025-12-15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2025-12-15 |
| DSQ | Ventricular (Assist) Bypass | Unknown | Class 3 | N/A | 2025-12-15 |
| NVM | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2025-12-15 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | General, Plastic Surgery | Class 2 | 878.5000 | 2025-12-15 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2025-12-15 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | Class 2 | 878.4840 | 2025-12-15 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2025-12-15 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2025-12-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2025-12-15 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2025-12-15 |
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | General, Plastic Surgery | Class 2 | 878.4400 | 2025-12-15 |
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| NUN | Bone Grafting Material, Human Source | Dental | Class 2 | 872.3930 | 2025-12-15 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2025-12-15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| FEQ | Pump, Air, Non-Manual, For Endoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-12-15 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2025-12-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2025-12-15 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3660 | 2025-12-15 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2025-12-15 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3650 | 2025-12-15 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2025-12-15 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-15 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3670 | 2026-04-30 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2026-04-30 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2026-04-30 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2026-04-30 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3650 | 2026-04-30 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2025-12-15 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2025-12-15 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2025-12-15 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2025-12-15 |
| NPV | Pulmonary Valve Prosthesis Percutaneously Delivered | Unknown | Class f | N/A | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2025-12-15 |
| FDI | Snare, Flexible | Gastroenterology, Urology | Class 2 | 876.4300 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-12-15 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | Class 2 | 870.1310 | 2025-12-15 |
| FDX | Endoscopic Cytology Brush | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-12-15 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2025-12-15 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2026-04-30 |
| KGC | Tube, Gastro-Enterostomy | Gastroenterology, Urology | Class 2 | 876.5980 | 2026-04-30 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-04-30 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2025-12-15 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2025-12-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-12-15 |
| OCM | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation | Unknown | Class 3 | N/A | 2025-12-15 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2025-12-15 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2025-12-15 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2025-12-15 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K043580 | Chestnut Medical Technologies, Inc. | ALLIGATOR RETRIEVAL DEVICE (ARD) | 2005-03-24 |
| K982883 | Medtronics Interventional Vascular | MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER | 1998-09-04 |
| K132420 | Reflow Medical | WINGMAN EXTENDABLE TIP SUPPORT CATHETER | 2013-09-19 |
| K082339 | Endocross, Ltd. | ENABLER-P SUPPORT CATHETER | 2008-11-20 |
| K210009 | CenterPoint Systems, LLC | Guiding Catheter | 2021-11-24 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0001-2010 | Penumbra Inc. | 2 | Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA.
Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
| Z-0003-2014 | Cordis Corporation | 2 | Cordis ADROIT 6F Guiding Catheter
Product Usage:
For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. |
| Z-0009-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter |
| Z-0010-04 | Bard Peripheral Vascular | 2 | Conquest Balloon Dilation Catheters
Model/Catalog Number CQ 75124 |
| Z-0010-2024 | Boston Scientific Corporation | 2 | Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3039062605 | CORVITEX CORPORATION | Raleigh, NC, US |
| 3031768596 | PIRAEUS MEDICAL, INC. | Maple Grove, MN, US |
| 3013134719 | HEXACATH | Rueil Malmaison Ile-de-France, FR |
| 3011142981 | Rontis Hellas S.A. | Larisa Thessalia, GR |
| 3010370269 | STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD | Cape Town Western Cape, ZA |
2528981 when referencing this establishment in official correspondence.