FDA Device Registration & Listing · Frittlingen Baden-Wurttemberg, DE · Registration 3002862271
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 |
|---|---|---|---|---|---|
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2016-12-17 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-17 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-07-22 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-12-20 |
| KBQ | Knife, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-17 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-17 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-09-07 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-17 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2020-11-16 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2020-11-16 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2016-12-17 |
| HWR | Driver, Prosthesis | Orthopedic | Class 1 | 888.4540 | 2016-12-17 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2016-12-17 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-17 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-17 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2016-12-17 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-12-17 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-17 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2020-11-16 |
| NNR | Block, Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2020-11-16 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2016-12-17 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-17 |
| JEY | Plate, Bone | Dental | Class 2 | 872.4760 | 2020-11-16 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3022747125 | Stehle Medizintechnik | Renquishausen Baden-Wurttemberg, DE |
| 3013497507 | Teufel & Gerlach GmbH | Tuttlingen Baden-Wurttemberg, DE |
| 3003322138 | Kreidler Medizintechnik GmbH | Wurmlingen Baden-Wurttemberg, DE |
| 8010099 | MEDICON, E.G. | TUTTLINGEN Baden-Wurttemberg, DE |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K881095 | CooperVision, Inc. | KOI(TM) INSTRUMENT TRAYS | 1988-04-06 |
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| K820290 | The Anspach Effort, Inc. | SELF RETAINING RETRACTOR FOR HAND SURG | 1982-03-05 |
| K760422 | Cutter Laboratories, Inc. | SURGICAL RETRACTOR | 1976-08-23 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3012995405 | SURGIX MEDICAL LLC | Spring, TX, US |
| 8010733 | PRO-MED INSTRUMENTE GMBH | TUTTLINGEN Baden-Wurttemberg, DE |
| 3015895045 | Sklar Corporation - Warehouse | Salisbury, MD, US |
| 2132732 | TECOMET, INC. | KENOSHA, WI, US |
| 9616671 | DEPUY (IRELAND) | CO. CORK Munster, IE |
3002862271 when referencing this establishment in official correspondence.