FDA Device Registration & Listing · Franklin, NJ, US · Registration 2244478
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2026-03-26 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | Cardiovascular | Class 1 | 870.4200 | 2026-01-20 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2026-01-20 |
| HBA | Neurosurgical Paddie | Neurology | Class 2 | 882.4700 | 2025-12-29 |
| OOE | Ophthalmic Femtosecond Laser | Ophthalmic | Class 2 | 886.4390 | 2025-12-16 |
| FQH | Lavage, Jet | General Hospital | Class 2 | 880.5475 | 2026-01-20 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-12-16 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-03-18 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2026-03-18 |
| OAB | Low Energy Direct Current Thermal Ablation System | General, Plastic Surgery | Class 2 | 878.4400 | 2026-01-20 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3660 | 2026-02-19 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2026-02-19 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2026-02-19 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2026-02-19 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3650 | 2026-02-19 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2026-03-24 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4160 | 2026-03-18 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4150 | 2026-03-18 |
| OJK | Eye Tray | Ophthalmic | Class 2 | 886.4790 | 2025-12-29 |
| FPA | Set, Administration, Intravascular | General Hospital | Class 2 | 880.5440 | 2026-01-20 |
| FRN | Pump, Infusion | General Hospital | Class 2 | 880.5725 | 2026-01-20 |
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | Class 2 | 880.5725 | 2026-01-20 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2026-03-24 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| FTM | Mesh, Surgical | General, Plastic Surgery | Class 2 | 878.3300 | 2025-12-18 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-03-24 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | General, Plastic Surgery | Class 1 | 878.4450 | 2025-12-29 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2026-01-20 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-18 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-03-24 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2025-12-16 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-16 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-03-24 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-03-18 |
| HET | Laparoscope, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1720 | 2026-03-18 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | Orthopedic | Class 2 | 888.3400 | 2026-03-24 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2026-03-18 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2026-01-20 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2026-03-24 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-12-22 |
| OCX | Endoscopic Irrigation/Suction System | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-03-18 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-12-29 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2025-12-17 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2026-03-24 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-02-19 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2026-02-19 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2026-02-19 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3350 | 2026-02-19 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-02-19 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Orthopedic | Class 2 | 888.3353 | 2026-02-19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-03-24 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2026-03-24 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | General, Plastic Surgery | Class 2 | 878.4780 | 2025-12-18 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2026-03-18 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2026-03-24 |
| GEJ | Carrier, Ligature | General, Plastic Surgery | Class 1 | 878.4800 | 2026-01-20 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2026-01-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2026-01-08 |
| LHI | Set, I.V. Fluid Transfer | General Hospital | Class 2 | 880.5440 | 2026-01-20 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | Class 1 | 878.4680 | 2026-01-20 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2026-03-18 |
| OOE | Ophthalmic Femtosecond Laser | Ophthalmic | Class 2 | 886.4390 | 2025-12-16 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-12-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2026-03-18 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2026-03-24 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3530 | 2026-03-24 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2026-03-24 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2026-03-24 |
| GAX | Tourniquet, Nonpneumatic | General, Plastic Surgery | Class 1 | 878.5900 | 2025-12-24 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2026-02-19 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2026-02-19 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2026-02-19 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | General, Plastic Surgery | Class 2 | 878.5000 | 2025-12-16 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2026-03-18 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2026-01-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2026-03-18 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2026-03-24 |
| LXC | Monitor, Pressure, Intracompartmental | Unknown | Class U | N/A | 2025-12-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2026-03-18 |
| NVT | Tubing And Tubing/Filter Fits | Obstetrics/Gynecology | Class 1 | 884.1700 | 2026-03-18 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2026-01-20 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-12-22 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2026-03-24 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2026-01-20 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2026-02-19 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2026-02-19 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3660 | 2026-02-19 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3650 | 2026-02-19 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2026-01-20 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2026-03-24 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | Orthopedic | Class 2 | 888.3770 | 2026-03-24 |
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | General, Plastic Surgery | Class 2 | 878.5020 | 2025-12-18 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2026-03-24 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2026-02-19 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2026-02-19 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2026-02-19 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2026-03-18 |
| GAB | Needle, Suturing, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2025-12-16 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-05-22 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | General Hospital | Class 2 | 880.6740 | 2026-01-20 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2025-12-16 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2026-03-18 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2026-03-24 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2025-12-22 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2026-03-18 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2026-02-19 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2026-02-19 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2026-02-19 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2026-02-19 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3540 | 2026-02-19 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2026-02-19 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3510 | 2026-02-19 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2026-01-20 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | Orthopedic | Class 2 | 888.3770 | 2026-03-24 |
| HBA | Neurosurgical Paddie | Neurology | Class 2 | 882.4700 | 2025-12-29 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-02-04 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2026-03-18 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2026-02-19 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2026-03-18 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2026-03-24 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-03-24 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | Orthopedic | Class 2 | 888.3770 | 2026-03-24 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2026-01-20 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2026-01-20 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-03-24 |
| CAL | Laryngoscope, Non-Rigid | Anesthesiology | Class 1 | 868.5530 | 2026-03-18 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2026-03-18 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2025-12-16 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K832124 | Med-West, Inc. | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI | 1983-08-12 |
| K162500 | Spyder Medical | Ostial Sprit Cannulae | 2017-01-12 |
| K170322 | Abbott Medical Optics, Inc. | Catalys Precision Laser System | 2017-05-19 |
| K213616 | Becton, Dickinson and Company | BD Surgiphor Antimicrobial Irrigation System | 2022-03-23 |
| K072322 | Smith & Nephew, Inc. | ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS | 2007-09-18 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0003-2022 | Medtronic Perfusion Systems | 2 | Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile. |
| Z-0021-2018 | OriGen Biomedical, Inc. | 2 | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position. |
| Z-1515-2015 | Abbott Medical Optics, Inc. | 2 | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US).
Product Usage:
Indicated for use in patients undergoing cataract surgery for removal of crystalline lens. |
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005061536 | SYMMETRY MEDICAL MANUFACTURING INC | CLAYPOOL, IN, US |
| 3007923096 | Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, CN |
| 3006801265 | Zhejiang Biomet Medical Products Co., Ltd. | Jinhua Zhejiang, CN |
| 2134285 | RIVERSIDE MACHINE & ENGINEERING, INC. | Eau Claire, WI, US |
| 9614209 | Corin Limited | CIRENCESTER Gloucestershire, GB |
2244478 when referencing this establishment in official correspondence.