FDA Device Registration & Listing · Derby Derbyshire, GB · Registration 3008559295
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| IZD | Probe, Uptake, Nuclear | Radiology | Class 1 | 892.1320 | 2022-12-22 |
| GAA | Needle, Aspiration And Injection, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2013-08-01 |
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | Class 1 | 886.4360 | 2013-08-01 |
| GXI | Probe, Radiofrequency Lesion | Neurology | Class 2 | 882.4725 | 2018-01-02 |
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | Class 1 | 872.4200 | 2020-01-07 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2013-08-01 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2013-08-01 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2013-08-01 |
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | Class 1 | 878.4020 | 2013-08-01 |
| HMQ | Marker, Sclera | Ophthalmic | Class 1 | 886.4570 | 2013-08-01 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2013-08-01 |
| PQM | Surgical Smoke Precipitator | General, Plastic Surgery | Class 2 | 878.5050 | 2022-12-22 |
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | Class 1 | 878.4018 | 2018-01-02 |
| OAT | Implant, Endosseous, Orthodontic | Dental | Class 2 | 872.3640 | 2018-01-02 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2025-02-12 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2024-05-31 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2018-01-02 |
| JDQ | Cerclage, Fixation | Orthopedic | Class 2 | 888.3010 | 2013-08-01 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2013-08-01 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2013-08-01 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2013-08-01 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2013-08-01 |
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | Unknown | Class U | N/A | 2013-08-01 |
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | Class 2 | 888.3045 | 2021-07-06 |
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | Obstetrics/Gynecology | Class 2 | 884.6130 | 2020-01-07 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2025-02-04 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-02-04 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2025-02-04 |
| JDR | Staple, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2025-02-04 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2018-01-10 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2018-01-10 |
| EZL | Catheter, Retention Type, Balloon | Gastroenterology, Urology | Class 2 | 876.5130 | 2025-02-04 |
| KDD | Kit, Surgical Instrument, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2018-01-02 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K942580 | Neoprobe Corp. | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | 1995-02-09 |
| K781371 | Ferris Mfg. Corp. | BONE MARROW ASPIRATION KIT | 1978-09-20 |
| K253907 | ABBOTT MEDICAL | Disposable Radiofrequency Cannula | 2026-04-16 |
| K242841 | ABBOTT MEDICAL | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | 2025-05-27 |
| K241065 | Dentis Co., Ltd. | ChecQ (AC100) | 2025-03-21 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0017-2023 | Hobbs Medical, Inc. | 1 | Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe
Catalog Number: 4620 |
| Z-0018-2023 | Hobbs Medical, Inc. | 1 | Hobbs Transbronchial Aspiration Needle
Catalog Number: 4621 |
| Z-0023-2011 | Becton Dickinson & Company | 1 | BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106.
Needles are intended for use in aspiration and injection of medications. |
| Z-0720-2020 | Abbott Medical | 2 | CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion. |
| Z-0013-2019 | COVIDIEN LLC | 1 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332
Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3010027290 | SOUTHERN SCIENTIFIC LTD | Henfield West Sussex, GB |
| 3029904425 | Lightpoint Surgical Limited | AMERSHAM Hertfordshire, GB |
| 1220477 | ISOMEDIX OPERATIONS INC. | Northborough, MA, US |
| 2031874 | INTRAMEDICAL IMAGING LLC. | Los Angeles, CA, US |
| 3010273872 | Synergy Health AST, SRL | Alajuela, CR |
3008559295 when referencing this establishment in official correspondence.