FDA Device Registration & Listing · Minneapolis, MN, US · Registration 2183744
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2022-11-21 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2021-01-12 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2012-12-28 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2012-12-19 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | Class 2 | 864.9245 | 2020-12-03 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2024-05-13 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2024-12-17 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2024-02-07 |
| LIO | Device, Specimen Collection | Microbiology | Class 1 | 866.2900 | 2022-12-19 |
| QXB | Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia | Unknown | Class 3 | N/A | 2024-05-24 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2022-11-03 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2013-01-08 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-11-13 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2018-02-28 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2012-12-19 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2022-10-26 |
| HGI | Electrocautery, Gynecologic (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4120 | 2012-12-18 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2012-12-18 |
| QRB | Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | Unknown | Class 3 | N/A | 2026-03-25 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Unknown | Class 3 | N/A | 2026-03-25 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | General, Plastic Surgery | Class 2 | 878.3300 | 2014-05-12 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2025-01-13 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2024-12-17 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2024-12-17 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2024-12-17 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2024-12-17 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | Class 2 | 892.1550 | 2024-05-30 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2024-05-30 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2019-12-31 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | General Hospital | Class 2 | 880.5970 | 2017-08-23 |
| BSR | Stylet, Tracheal Tube | Anesthesiology | Class 1 | 868.5790 | 2014-03-03 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2025-11-20 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2024-04-15 |
| LJE | Catheter, Nephrostomy | Unknown | Class U | N/A | 2023-10-30 |
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | Unknown | Class 3 | N/A | 2014-11-11 |
| NHI | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | Neurology | Class 2 | 882.5890 | 2023-02-15 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | General Hospital | Class 2 | 880.5970 | 2017-08-23 |
| FCG | Biopsy Needle | Gastroenterology, Urology | Class 2 | 876.1075 | 2024-02-07 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2014-12-18 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2014-12-18 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2012-11-07 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| DSR | Stimulator, Carotid Sinus Nerve | Cardiovascular | Class 3 | 870.3850 | 2020-10-30 |
| GCT | Light Source, Endoscope, Xenon Arc | Gastroenterology, Urology | Class 2 | 876.1500 | 2024-03-25 |
| KCF | Dilator, Esophageal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-04-04 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2013-01-29 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Cardiovascular | Class 2 | 870.1250 | 2024-03-18 |
| NQJ | Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use | Gastroenterology, Urology | Class 2 | 876.5540 | 2024-04-03 |
| MSD | Catheter, Hemodialysis, Implanted | Gastroenterology, Urology | Class 2 | 876.5540 | 2024-04-03 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3530 | 2012-11-27 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3520 | 2012-11-27 |
| FEO | Lithotriptor, Ultrasonic | Gastroenterology, Urology | Class 2 | 876.4480 | 2024-02-07 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2015-02-09 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2025-08-14 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2025-08-14 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2025-01-13 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2013-01-08 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2024-10-16 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2012-12-19 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2013-01-29 |
| GAE | Snare, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2012-12-27 |
| IYE | Accelerator, Linear, Medical | Radiology | Class 2 | 892.5050 | 2023-09-25 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2020-01-30 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2024-02-07 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2024-01-31 |
| MMP | Cover, Barrier, Protective | General, Plastic Surgery | Class 2 | 878.4370 | 2022-08-13 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2013-01-29 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2024-01-31 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2017-01-03 |
| NIO | Stent, Iliac | Unknown | Class 3 | N/A | 2012-12-19 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2012-12-19 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Cardiovascular | Class 2 | 870.1250 | 2012-12-19 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2012-12-19 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2015-05-01 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2024-03-11 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-12-19 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2019-12-30 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2012-12-19 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2012-12-28 |
| GYC | Electrode, Cortical | Neurology | Class 2 | 882.1310 | 2012-12-18 |
| JSM | Culture Media, Non-Propagating Transport | Microbiology | Class 1 | 866.2390 | 2022-12-19 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2013-01-07 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2020-02-06 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2020-02-06 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2020-02-06 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2015-12-21 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2025-12-31 |
| KTI | Bronchoscope Accessory | Ear, Nose, Throat | Class 2 | 874.4680 | 2024-01-19 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2013-01-08 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2018-02-15 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2018-02-28 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2025-01-13 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| PNZ | Eustachian Tube Balloon Dilation Device | Ear, Nose, Throat | Class 2 | 874.4180 | 2018-01-09 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-01-09 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2013-01-29 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Gastroenterology, Urology | Class 2 | 876.5010 | 2013-01-29 |
| LJE | Catheter, Nephrostomy | Unknown | Class U | N/A | 2013-01-29 |
| EZB | Stylet For Catheter, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.5130 | 2013-01-29 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2013-01-29 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2013-01-29 |
| KNY | Accessories, Catheter, G-U | Gastroenterology, Urology | Class 2 | 876.5130 | 2013-01-29 |
| PEK | Spinous Process Plate | Orthopedic | Class 2 | 888.3050 | 2020-12-11 |
| FST | Light, Surgical, Fiberoptic | General, Plastic Surgery | Class 2 | 878.4580 | 2014-03-03 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2012-11-08 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | Class 2 | 888.3080 | 2020-12-11 |
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | Class 2 | 870.3300 | 2013-01-08 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| MVR | Device, Anastomotic, Microvascular | General, Plastic Surgery | Class 2 | 878.4300 | 2024-05-30 |
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | Class 2 | 870.2100 | 2024-05-30 |
| BYY | Tube, Aspirating, Flexible, Connecting | General Hospital | Class 2 | 880.6740 | 2012-11-15 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2020-01-30 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2025-11-25 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | Class 2 | 870.1425 | 2025-11-25 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2013-01-07 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2013-02-01 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2023-09-13 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2012-12-27 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2015-12-30 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2015-12-30 |
| SEL | Securement Wound Dressing For Reduction Of Infection | Unknown | Class U | N/A | 2022-01-11 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| DRA | Catheter, Steerable | Cardiovascular | Class 2 | 870.1280 | 2026-02-10 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| JSM | Culture Media, Non-Propagating Transport | Microbiology | Class 1 | 866.2390 | 2022-12-19 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2020-11-12 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2012-12-19 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2013-01-08 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2022-08-13 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2022-08-13 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | Cardiovascular | Class 2 | 870.1250 | 2020-11-10 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2024-01-31 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2013-01-29 |
| DYX | Lock, Wire, And Ligature, Intraoral | Dental | Class 2 | 872.4600 | 2024-06-20 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2024-10-31 |
| FCZ | Tube, Smoke Removal, Endoscopic | Gastroenterology, Urology | Class 1 | 876.1500 | 2012-12-27 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2012-12-27 |
| NRY | Catheter, Thrombus Retriever | Cardiovascular | Class 2 | 870.1250 | 2018-05-31 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2012-12-19 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2012-12-19 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2017-05-30 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2017-05-30 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2025-12-16 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2025-12-16 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-02-01 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-02-01 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2013-01-29 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2024-10-21 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2014-04-08 |
| LZU | Plug, Punctum | Unknown | Class U | N/A | 2021-07-07 |
| JAK | System, X-Ray, Tomography, Computed | Radiology | Class 2 | 892.1750 | 2024-02-01 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-08 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2025-11-20 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2025-01-13 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | Cardiovascular | Class 2 | 870.5150 | 2014-12-18 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2025-01-13 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2019-10-17 |
| MOS | Coil, Magnetic Resonance, Specialty | Radiology | Class 2 | 892.1000 | 2020-01-29 |
| QJP | Catheter, Percutaneous, Neurovasculature | Cardiovascular | Class 2 | 870.1250 | 2025-11-20 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-11-20 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Cardiovascular | Class 2 | 870.1250 | 2020-11-03 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2020-11-03 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-08 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2020-01-13 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2012-12-19 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2013-01-08 |
| HAX | Tong, Skull For Traction | Neurology | Class 2 | 882.5960 | 2012-12-18 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2024-02-07 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2013-01-29 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2024-06-19 |
| PWK | Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse | Obstetrics/Gynecology | Class 2 | 884.4910 | 2024-06-19 |
| GZL | Electrode, Depth | Neurology | Class 2 | 882.1330 | 2012-12-18 |
| PCX | Artificial Chordae Tendinae Delivery System | Unknown | Class N | N/A | 2024-04-10 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2013-11-27 |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | Class 2 | 882.5870 | 2024-04-12 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | General, Plastic Surgery | Class 2 | 878.3300 | 2014-05-12 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | Class 2 | 882.5880 | 2024-04-16 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2013-01-30 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2024-04-08 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2013-01-07 |
| KKX | Drape, Surgical, Antimicrobial | General, Plastic Surgery | Class 2 | 878.4370 | 2022-08-13 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| KAM | Cannula, Sinus | General, Plastic Surgery | Class 1 | 878.4800 | 2024-06-20 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2013-09-11 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Cardiovascular | Class 2 | 870.1250 | 2022-04-08 |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | Ophthalmic | Class 2 | 886.1385 | 2015-05-30 |
| NIO | Stent, Iliac | Unknown | Class 3 | N/A | 2018-09-01 |
| PDU | Catheter For Crossing Total Occlusions | Cardiovascular | Class 2 | 870.1250 | 2013-02-01 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2012-12-19 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | Class 2 | 870.1200 | 2019-10-17 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | General, Plastic Surgery | Class 2 | 878.3300 | 2014-05-12 |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | Hematology | Class 2 | 864.9205 | 2015-02-19 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2012-12-18 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | Class 2 | 888.3730 | 2026-03-16 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | Cardiovascular | Class 2 | 870.1250 | 2020-11-10 |
| GZL | Electrode, Depth | Neurology | Class 2 | 882.1330 | 2012-12-18 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2018-01-25 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2015-12-21 |
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | Class 2 | 882.5880 | 2024-04-16 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2022-11-21 |
| KNY | Accessories, Catheter, G-U | Gastroenterology, Urology | Class 2 | 876.5130 | 2025-01-13 |
| DWZ | Device, Biopsy, Endomyocardial | Cardiovascular | Class 2 | 870.4075 | 2013-01-29 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| PRC | Drug-Coated Peripheral Transluminal Angioplasty Catheter | Unknown | Class 3 | N/A | 2017-08-30 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2025-09-08 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | Class 2 | 870.1200 | 2019-12-19 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2015-12-21 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | Class 2 | 870.1200 | 2013-01-29 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | Class 2 | 892.1570 | 2022-08-13 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4160 | 2012-12-18 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| LFB | Button, Nasal Septal | Unknown | Class U | N/A | 2012-12-18 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-12-19 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2018-12-19 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2018-12-19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-12-19 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2018-12-19 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2015-02-10 |
| MLV | Transcatheter Septal Occluder | Unknown | Class 3 | N/A | 2013-01-08 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2021-01-12 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| LYA | Splint, Intranasal Septal | Ear, Nose, Throat | Class 1 | 874.4780 | 2013-01-30 |
| GXD | Generator, Lesion, Radiofrequency | Neurology | Class 2 | 882.4400 | 2024-01-04 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2024-01-04 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2020-01-29 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2014-11-04 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-05-12 |
| EYB | Catheter, Ureteral, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.5130 | 2012-12-18 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | Class 2 | 876.5860 | 2020-11-13 |
| MLV | Transcatheter Septal Occluder | Unknown | Class 3 | N/A | 2019-11-22 |
| MGB | Device, Hemostasis, Vascular | Unknown | Class 3 | N/A | 2013-01-30 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2014-09-15 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2014-09-15 |
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | General, Plastic Surgery | Class 2 | 878.5040 | 2024-06-21 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-02-01 |
| OKC | Implanted Subcutaneous Securement Catheter | General Hospital | Class 2 | 880.5970 | 2012-11-27 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2012-11-27 |
| KDQ | Bottle, Collection, Vacuum | General Hospital | Class 2 | 880.6740 | 2012-12-27 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2012-12-18 |
| MCX | Catheter, Coronary, Atherectomy | Unknown | Class 3 | N/A | 2014-03-14 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-01-13 |
| QNW | Reprocessed Bronchoscope | Ear, Nose, Throat | Class 2 | 874.4680 | 2021-05-11 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | Unknown | Class U | N/A | 2025-08-25 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2020-01-29 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2024-06-19 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | Class 2 | 878.4840 | 2024-06-19 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2020-02-06 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2020-02-06 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2019-10-17 |
| EXF | Bag, Bile Collecting | Gastroenterology, Urology | Class 2 | 876.5010 | 2017-11-08 |
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | Class 2 | 870.5150 | 2020-01-29 |
| HIF | Insufflator, Laparoscopic | Obstetrics/Gynecology | Class 2 | 884.1730 | 2012-12-19 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-02-02 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2015-02-02 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2015-02-02 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2015-02-02 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2026-03-30 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-12-19 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | Gastroenterology, Urology | Class 3 | 876.5270 | 2013-01-30 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2024-02-07 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2013-01-29 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2012-12-19 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2017-11-09 |
| QAN | Stent, Iliac Vein | Unknown | Class 3 | N/A | 2024-05-13 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2024-02-07 |
| NGV | System, Appendage Closure, Left Atrial | Unknown | Class 3 | N/A | 2015-04-07 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2015-12-21 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2015-05-26 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2024-12-18 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2024-12-18 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2024-12-18 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | Orthopedic | Class 2 | 888.3800 | 2024-12-18 |
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | Obstetrics/Gynecology | Class 2 | 884.4530 | 2024-06-19 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2021-01-12 |
| QAN | Stent, Iliac Vein | Unknown | Class 3 | N/A | 2023-08-03 |
| NEU | Marker, Radiographic, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2023-04-10 |
| LGZ | Warmer, Thermal, Infusion Fluid | General Hospital | Class 2 | 880.5725 | 2015-02-19 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | Class 2 | 874.4250 | 2025-01-13 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2015-12-21 |
| GWG | Endoscope, Neurological | Neurology | Class 2 | 882.1480 | 2024-03-25 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2015-12-21 |
| QEZ | Aspiration Thrombectomy Catheter | Cardiovascular | Class 2 | 870.5150 | 2013-01-07 |
| KRA | Catheter, Continuous Flush | Cardiovascular | Class 2 | 870.1210 | 2013-01-07 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Cardiovascular | Class 2 | 870.1220 | 2016-12-13 |
| PNZ | Eustachian Tube Balloon Dilation Device | Ear, Nose, Throat | Class 2 | 874.4180 | 2024-07-12 |
| FJL | Resectoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-11-23 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2020-11-23 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.1690 | 2020-11-23 |
| FDC | Resectoscope, Working Element | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-11-23 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Cardiovascular | Class 2 | 870.4210 | 2014-03-03 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2012-12-18 |
| FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology | Class 3 | 876.3350 | 2012-12-28 |
| MJN | Catheter, Intravascular Occluding, Temporary | Cardiovascular | Class 2 | 870.4450 | 2021-01-13 |
| DQO | Catheter, Intravascular, Diagnostic | Cardiovascular | Class 2 | 870.1200 | 2021-01-13 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2021-01-13 |
| NWJ | Suture, Recombinant Technology | General, Plastic Surgery | Class 2 | 878.4494 | 2015-05-30 |
| GBO | Catheter, Nephrostomy, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4200 | 2023-10-30 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2012-12-19 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2024-02-07 |
| KMF | Bandage, Liquid | General Hospital | Class 1 | 880.5090 | 2018-01-25 |
| KWH | Prosthesis, Toe, Constrained, Polymer | Orthopedic | Class 2 | 888.3720 | 2015-02-10 |
| OKC | Implanted Subcutaneous Securement Catheter | General Hospital | Class 2 | 880.5970 | 2024-09-16 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2024-09-16 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | General, Plastic Surgery | Class 1 | 878.4680 | 2012-12-27 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2019-10-17 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2013-01-29 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2013-01-29 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | Cardiovascular | Class 2 | 870.1200 | 2019-10-17 |
| NIQ | Coronary Drug-Eluting Stent | Unknown | Class 3 | N/A | 2024-01-05 |
| PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | Cardiovascular | Class 2 | 870.1252 | 2019-11-13 |
| KNQ | Dilator, Esophageal | Gastroenterology, Urology | Class 2 | 876.5365 | 2013-02-01 |
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | Class 2 | 868.5730 | 2024-04-04 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | Class 2 | 880.5570 | 2024-07-16 |
| MEG | Syringe, Antistick | General Hospital | Class 2 | 880.5860 | 2024-07-16 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2024-07-16 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| FGO | Dislodger, Stone, Flexible | Gastroenterology, Urology | Class 2 | 876.4680 | 2013-01-07 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2013-01-30 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2012-12-27 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-05-12 |
| GBA | Catheter, Balloon Type | General, Plastic Surgery | Class 1 | 878.4200 | 2013-01-07 |
| LIO | Device, Specimen Collection | Microbiology | Class 1 | 866.2900 | 2022-12-19 |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | Cardiovascular | Class 2 | 870.1250 | 2012-12-19 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2016-01-25 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2024-10-16 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2013-12-18 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | Class 2 | 888.3030 | 2019-10-17 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2013-02-01 |
| HAW | Neurological Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2012-12-19 |
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | Unknown | Class U | N/A | 2024-02-26 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2024-02-26 |
| DTB | Permanent Pacemaker Electrode | Cardiovascular | Class 3 | 870.3680 | 2024-10-21 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2024-02-07 |
| NIP | Stent, Superficial Femoral Artery | Unknown | Class 3 | N/A | 2012-12-19 |
| EZW | Stimulator, Electrical, Implantable, For Incontinence | Gastroenterology, Urology | Class 3 | 876.5270 | 2013-01-30 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2013-01-29 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2012-12-19 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2019-12-31 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2014-06-20 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2012-12-19 |
| GWG | Endoscope, Neurological | Neurology | Class 2 | 882.1480 | 2024-03-25 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-07 |
| PWI | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse | Obstetrics/Gynecology | Class 2 | 884.4910 | 2019-12-30 |
| MSR | Tubing, Replacement, Phacofragmentation Unit | Ophthalmic | Class 2 | 886.4150 | 2023-12-14 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | Cardiovascular | Class 2 | 870.1220 | 2025-02-20 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2022-01-28 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2013-11-18 |
| QHJ | Sensor, Glucose, Implanted, Non-Adjunctive Use | Unknown | Class 3 | N/A | 2020-03-12 |
| QCD | Continuous Glucose Monitor, Implanted, Adjunctive Use | Unknown | Class 3 | N/A | 2020-03-12 |
| FTM | Mesh, Surgical | General, Plastic Surgery | Class 2 | 878.3300 | 2012-12-18 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2020-11-23 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2012-11-16 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2015-05-01 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2021-01-12 |
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | Unknown | Class 3 | N/A | 2018-02-15 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-07-12 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2012-12-28 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2020-01-30 |
| OKC | Implanted Subcutaneous Securement Catheter | General Hospital | Class 2 | 880.5970 | 2020-01-30 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2020-01-29 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-09-13 |
| PNZ | Eustachian Tube Balloon Dilation Device | Ear, Nose, Throat | Class 2 | 874.4180 | 2023-09-13 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2024-12-17 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2024-12-17 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2019-12-31 |
| LFL | Instrument, Ultrasonic Surgical | Unknown | Class U | N/A | 2024-02-07 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2024-02-07 |
| GWG | Endoscope, Neurological | Neurology | Class 2 | 882.1480 | 2024-03-25 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2012-12-27 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2018-10-16 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2024-12-18 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2024-12-18 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Cardiovascular | Class 2 | 870.1310 | 2020-01-30 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2012-12-18 |
| MVR | Device, Anastomotic, Microvascular | General, Plastic Surgery | Class 2 | 878.4300 | 2024-05-30 |
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | Class 2 | 870.2100 | 2024-05-30 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2013-10-31 |
| MLV | Transcatheter Septal Occluder | Unknown | Class 3 | N/A | 2019-11-21 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2012-11-07 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2018-02-28 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2016-03-29 |
| DXE | Catheter, Embolectomy | Cardiovascular | Class 2 | 870.5150 | 2012-12-19 |
| FFK | Lithotriptor, Electro-Hydraulic | Gastroenterology, Urology | Class 2 | 876.4480 | 2023-09-13 |
| FMF | Syringe, Piston | General Hospital | Class 2 | 880.5860 | 2019-01-10 |
| OUG | Medical Device Data System | General Hospital | Class 1 | 880.6310 | 2011-11-11 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2013-01-29 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2025-05-12 |
| GBP | Catheter, Multiple Lumen | General, Plastic Surgery | Class 1 | 878.4200 | 2024-07-12 |
| HJK | Lens, Contact, Polymethylmethacrylate, Diagnostic | Ophthalmic | Class 2 | 886.1385 | 2023-10-25 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2018-12-19 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2018-12-19 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2013-01-07 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Cardiovascular | Class 2 | 870.1250 | 2018-01-19 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2012-12-18 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2017-11-21 |
| KTI | Bronchoscope Accessory | Ear, Nose, Throat | Class 2 | 874.4680 | 2017-11-21 |
| FDX | Endoscopic Cytology Brush | Gastroenterology, Urology | Class 2 | 876.1500 | 2020-03-16 |
| ETD | Tube, Tympanostomy | Ear, Nose, Throat | Class 2 | 874.3880 | 2022-08-04 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2012-12-19 |
| FRO | Dressing, Wound, Drug | Unknown | Class U | N/A | 2012-12-20 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2013-01-08 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2012-12-19 |
| IKD | Cable, Electrode | Physical Medicine | Class 2 | 890.1175 | 2012-10-31 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2020-01-29 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2020-01-29 |
| DTD | Pacemaker Lead Adaptor | Cardiovascular | Class 2 | 870.3620 | 2024-10-21 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2022-02-15 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-07 |
| MRW | System, Facet Screw Spinal Device | Unknown | Class U | N/A | 2018-02-28 |
| NIM | Stent, Carotid | Unknown | Class 3 | N/A | 2024-11-04 |
| GYC | Electrode, Cortical | Neurology | Class 2 | 882.1310 | 2021-12-07 |
| NLH | Catheter, Recording, Electrode, Reprocessed | Cardiovascular | Class 2 | 870.1220 | 2013-01-29 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2021-01-12 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2021-01-12 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2012-12-27 |
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | Class 2 | 870.4875 | 2014-03-14 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| GXR | Cover, Burr Hole | Neurology | Class 2 | 882.5250 | 2012-12-19 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2022-02-16 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2021-01-12 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2025-01-13 |
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | Class 1 | 880.6025 | 2012-11-14 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-08 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2018-05-08 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2024-12-17 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2024-12-17 |
| DWJ | System, Thermal Regulating | Cardiovascular | Class 2 | 870.5900 | 2015-02-19 |
| KOE | Dilator, Urethral | Gastroenterology, Urology | Class 2 | 876.5520 | 2024-05-24 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2015-05-01 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| NTE | Temporary Carotid Catheter For Embolic Capture | Cardiovascular | Class 2 | 870.1250 | 2024-03-11 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2024-03-11 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-12-19 |
| LYA | Splint, Intranasal Septal | Ear, Nose, Throat | Class 1 | 874.4780 | 2018-05-08 |
| LWR | Heart-Valve, Non-Allograft Tissue | Unknown | Class 3 | N/A | 2021-02-02 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2024-02-07 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2024-12-17 |
| FTM | Mesh, Surgical | General, Plastic Surgery | Class 2 | 878.3300 | 2019-12-04 |
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Unknown | Class 3 | N/A | 2018-05-08 |
| QRB | Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | Unknown | Class 3 | N/A | 2018-05-08 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Orthopedic | Class 2 | 888.3358 | 2018-05-08 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2018-05-08 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2018-05-08 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2018-05-08 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | General, Plastic Surgery | Class 2 | 878.3300 | 2023-02-16 |
| FTM | Mesh, Surgical | General, Plastic Surgery | Class 2 | 878.3300 | 2023-02-16 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Orthopedic | Class 2 | 888.3110 | 2024-12-17 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2013-01-07 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | Class 2 | 888.3040 | 2024-12-18 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2025-09-09 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | General, Plastic Surgery | Class 2 | 878.4493 | 2022-02-15 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | General, Plastic Surgery | Class 2 | 878.5010 | 2022-02-15 |
| NZC | Stent, Urethral, Prostatic, Semi-Permanent | Unknown | Class 3 | N/A | 2015-12-22 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2023-04-19 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2012-12-28 |
| MAE | Occluder, Patent Ductus, Arteriosus | Unknown | Class 3 | N/A | 2013-01-08 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2024-04-08 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2022-11-21 |
| KMK | Device, Intravascular Catheter Securement | General Hospital | Class 1 | 880.5210 | 2021-12-02 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-12-18 |
| FAD | Stent, Ureteral | Gastroenterology, Urology | Class 2 | 876.4620 | 2025-01-13 |
| EMX | Balloon, Epistaxis | Ear, Nose, Throat | Class 1 | 874.4100 | 2012-12-27 |
| LCJ | Tissue Expander And Accessories | Unknown | Class U | N/A | 2012-10-18 |
| DXF | Catheter, Septostomy | Cardiovascular | Class 2 | 870.5175 | 2024-04-12 |
| DYB | Introducer, Catheter | Cardiovascular | Class 2 | 870.1340 | 2024-04-12 |
| DPW | Flowmeter, Blood, Cardiovascular | Cardiovascular | Class 2 | 870.2100 | 2025-09-09 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | Class 2 | 878.4810 | 2015-05-01 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-02-01 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | Class 2 | 874.1820 | 2016-11-22 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Orthopedic | Class 2 | 888.3030 | 2020-10-22 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | General Hospital | Class 2 | 880.5970 | 2017-08-23 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | Class 2 | 888.3080 | 2013-06-03 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | Obstetrics/Gynecology | Class 1 | 884.1730 | 2015-08-06 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Gastroenterology, Urology | Class 2 | 876.5010 | 2012-12-19 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2020-01-29 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-02-01 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | Class 2 | 876.5860 | 2025-12-02 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-01-29 |
| GWM | Device, Monitoring, Intracranial Pressure | Neurology | Class 2 | 882.1620 | 2024-01-19 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2021-12-07 |
| JOS | Electrode, Electrosurgical | General, Plastic Surgery | Class 2 | 878.4400 | 2012-12-18 |
| EYB | Catheter, Ureteral, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.5130 | 2012-12-18 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | Class 2 | 870.1250 | 2015-12-21 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | Class 2 | 888.3070 | 2023-01-03 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2013-02-01 |
| DQX | Wire, Guide, Catheter | Cardiovascular | Class 2 | 870.1330 | 2024-03-21 |
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | Class 2 | 870.1425 | 2024-03-21 |
| DQY | Catheter, Percutaneous | Cardiovascular | Class 2 | 870.1250 | 2020-01-30 |
No official correspondent registered.
No US Agent registered (Local establishment).
| 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 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K970809 | Somnus Medical Technologies, Inc. | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | 1997-06-18 |
| K222793 | C.R. Bard, Inc. | WavelinQ Generator | 2022-10-17 |
| K002257 | Tecno Instruments (Pvt.) , Ltd. | TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 | 2000-10-19 |
| K193591 | Bowa-Electronics GmbH & Co. KG | ARC 400 | 2020-04-02 |
| K192128 | Sutter Medizintechnik GmbH | Sutter Arrowtip Monopolar Electrodes | 2019-10-04 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0031-06 | Rita Medical Systems | 2 | Rita Brand Habib 4X Electrosurgical Coagulator,
Catalog Number: 4401US;
Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826 |
| Z-0783-2020 | Abbott Medical | 2 | Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303 |
| Z-0789-2020 | Abbott Medical | 2 | Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential. |
| Z-0003-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes |
| Z-0004-04 | Liberty Medical Supplies | 2 | Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3007353760 | ENERGIST LIMITED | Swansea, GB |
| 3005064998 | RDI INC. | Mount Kisco, NY, US |
| 3020623326 | TRIWORKS GROUP S.R.L. | Palata Campobasso, IT |
| 3012616488 | BRERA MEDICAL INCORPORATED | Northborough, MA, US |
| 3012940012 | Sutter Medical Technologies USA Inc. | Alpharetta, GA, US |
2183744 when referencing this establishment in official correspondence.