FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 9611281
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 |
|---|---|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2012-12-12 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2014-11-29 |
| HTN | Washer, Bolt Nut | Orthopedic | Class 2 | 888.3030 | 2026-05-20 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2026-05-20 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 1999-03-08 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-01 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2013-02-04 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2014-11-26 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2014-12-02 |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | Orthopedic | Class 2 | 888.3030 | 2014-12-02 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2014-12-02 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2014-11-13 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2014-11-26 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2014-11-29 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2014-11-24 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1983-11-08 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 2014-12-01 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2006-06-07 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2014-11-13 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2014-11-13 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2014-11-13 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 1983-11-08 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 1998-10-01 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2020-12-09 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 1998-02-13 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2014-12-01 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2014-12-01 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2014-11-13 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2014-12-02 |
| OUR | Sacroiliac Joint Fixation | Orthopedic | Class 2 | 888.3040 | 2014-12-02 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2013-02-04 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2003-03-19 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2014-11-13 |
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-0034-2022 | Flower Orthopedics Corporation | 2 | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3016804805 | CLEARCAM | Austin, TX, US |
| 3011936016 | Sony Olympus Medical Solutions Inc. | Hachioji-shi Tokyo, JP |
| 3015335150 | VERNACARE LTD. | Chorley Lancashire, GB |
| 1221072 | VASCULAR TECHNOLOGY INCORPORATED | NASHUA, NH, US |
| 3021744308 | Lazurite Inc. | Cleveland, OH, US |
9611281 when referencing this establishment in official correspondence.