FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 8010168
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 |
|---|---|---|---|---|---|
| HCZ | Forceps, Surgical, Gynecological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2019-07-02 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 1978-03-28 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2018-04-25 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 1999-07-02 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 1978-03-28 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 1978-03-28 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 1999-07-02 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 1999-07-02 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 1983-09-27 |
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | Class 1 | 878.4950 | 2005-03-24 |
| GWG | Endoscope, Neurological | Neurology | Class 2 | 882.1480 | 2005-12-27 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2005-12-27 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 1999-07-02 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1999-07-02 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2013-01-31 |
| DWP | Dilator, Vessel, Surgical | Cardiovascular | Class 2 | 870.4475 | 2019-09-12 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2013-01-31 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 1999-07-02 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2007-12-03 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2012-11-21 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 1999-07-02 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1978-10-20 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1999-07-02 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1999-07-02 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-01-31 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 1999-07-02 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2010-11-12 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 1999-07-02 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2011-04-01 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 1999-07-02 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 1978-03-28 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 1981-10-30 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K914997 | Conmedcorp | ASP-IRRATOR | 1992-01-07 |
| K153773 | Olympus Medical Systems Corp. | Disposal Lens Cleaning Sheath | 2016-11-22 |
| K940141 | Micro-Medical Devices, Inc. | LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH | 1994-05-19 |
| K933812 | Advanced Surgical, Inc. | ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES | 1993-12-13 |
| K254228 | Karl Storz SE & CO. KG | KARL STORZ Trocars with Valve Seals | 2026-05-11 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures. |
| Z-0028-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures. |
| Z-0029-2009 | Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa | 2 | Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled
(2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures. |
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9680515 | TONTARRA MEDIZINTECHNIK GMBH | WURMLINGEN Baden-Wurttemberg, DE |
| 8040233 | QSA SURGICAL (PVT) LTD. | SIALKOT Punjab, PK |
| 3004215117 | MILLENNIUM SURGICAL CORP | Schaumburg, IL, US |
| 9710524 | ULTIMATE MEDICAL PRODUCTS LTD. | SHARJAH Ash Shariqah, AE |
| 2916714 | AESCULAP, INC. | CENTER VALLEY, PA, US |
8010168 when referencing this establishment in official correspondence.