FDA Device Registration & Listing · San Diego, CA, US · Registration 3023155873
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2022-12-12 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2022-12-12 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2022-12-12 |
| LXI | Guide, Drill, Ligament | General, Plastic Surgery | Class 1 | 878.4820 | 2022-12-12 |
| FWL | Camera, Cine, Endoscopic, Without Audio | General, Plastic Surgery | Class 1 | 878.4160 | 2023-05-23 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2022-12-12 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2022-12-13 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2022-12-12 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2022-12-12 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2022-12-12 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2022-12-12 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-13 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2022-12-12 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-12 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Anesthesiology | Class 2 | 868.5150 | 2023-01-20 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2022-12-12 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2022-12-12 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | Anesthesiology | Class 2 | 868.5150 | 2022-12-13 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K040797 | Britesmile, Inc. | BRITESMILE MASKING CREAM | 2004-04-02 |
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| 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 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| Z-0040-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 3mm Offset (Blue)
Catalog Number: 72201713
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0041-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 4mm Offset (Purple
Catalog Number: 72201714
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0042-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 5mm Offset (Red)
Catalog Number: 72201715
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Z-0043-2011 | Smith & Nephew, Inc. Endoscopy Division | 1 | Smith & Nephew Aimer Endofemoral 6mm Offset (Green)
Catalog Number: 72201716
ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1032347 | BIOMET MICROFIXATION | Jacksonville, FL, US |
| 3010726901 | EVONOS GMBH & CO. KG | Tuttlingen Baden-Wurttemberg, DE |
| 2084346 | MARINA MEDICAL INSTRUMENTS, INC. | Davie, FL, US |
| 3005440795 | XINHUA SURGICAL INSTRUMENT CO. LTD. | ZIBO Shandong, CN |
| 9610905 | KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, DE |
3023155873 when referencing this establishment in official correspondence.