FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 9680735
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 1997-12-18 |
| FZR | Contractor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 1997-12-18 |
| EIK | Carver, Wax, Dental | Dental | Class 1 | 872.4565 | 2013-07-12 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-07-12 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2013-07-12 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2013-07-12 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2024-11-22 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-07-12 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 1997-12-18 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 1997-12-18 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-07-12 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 1997-12-18 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2013-07-12 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 1997-07-24 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 1997-12-18 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 1997-07-24 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2013-07-12 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 1997-12-18 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 1997-07-24 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 1994-09-23 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2013-07-12 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 1997-12-18 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2024-03-15 |
| HTP | File | Orthopedic | Class 1 | 888.4540 | 2013-07-12 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2013-07-12 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 1997-12-18 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2013-07-12 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 1994-09-23 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 1997-12-18 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-07-12 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2013-07-12 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K834189 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #7 44/47 | 1984-03-06 |
| K243425 | Talladium España, SL | Guided DAS Surgical Kit | 2025-07-22 |
| K213209 | K1 Medical, LLC | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device | 2021-12-28 |
| K012105 | Symmetry Medical, Inc. | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | 2002-08-02 |
| K243317 | Infinitum Eta, Ltd. | NUVENTUS NV.C Surgical Cassette and Tray | 2025-02-11 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0034-2012 | X Spine Systems Inc | 1 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| 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 |
|---|---|---|
| 3014257776 | TDM CO.,LTD | Gwangju, KR |
| 8040884 | HILBRO (PVT) LTD. | SIALKOT Punjab, PK |
| 2248180 | CHARMANT U.S.A. | Morris Plains, NJ, US |
| 1043534 | WRIGHT MEDICAL TECHNOLOGY, INC. | Arlington, TN, US |
| 3017196117 | BRDH | Roden Drenthe, NL |
9680735 when referencing this establishment in official correspondence.