FDA Device Registration & Listing · Orange City, FL, US · Registration 3003687489
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-04 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-04 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2019-12-30 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-04 |
| NWV | Laparoscopic Accessories, Gynecologic | Obstetrics/Gynecology | Class 1 | 884.1720 | 2018-08-01 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2020-10-27 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-04 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2020-10-27 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-12-04 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-08-01 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | Obstetrics/Gynecology | Class 2 | 884.4150 | 2018-08-01 |
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | Class 1 | 874.4140 | 2024-12-04 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-04 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2020-10-27 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-08-01 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-04 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-04 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2024-12-04 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2024-12-04 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2018-08-01 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2024-12-04 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-08-01 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2008-01-09 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2024-12-04 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2024-12-04 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| 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-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-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Z-0010-2007 | Smith & Nephew Inc | 1 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 |
| Z-0011-06 | Stryker Howmedica Osteonics Corp. | 1 | Allocraft TLIF Bone Inserter. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016544015 | ARCULANT, INC. | Santa Clara, CA, US |
| 1055890 | PRINCETON MEDICAL GROUP, INC. | Franklin, TN, US |
| 3004371426 | Waldemar Link GmbH & Co. KG | Norderstedt Schleswig-Holstein, DE |
| 3010287737 | BAECHLER FEINTECH AG | Hoelstein Basel-Landschaft, CH |
| 3003675041 | SURGICAL INSTRUMENTS BELGIUM SA | GEMBLOUX Namur, BE |
3003687489 when referencing this establishment in official correspondence.