FDA Device Registration & Listing · Neuhausen ob Eck Baden-Wurttemberg, DE · Registration 3013784566
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 |
|---|---|---|---|---|---|
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-01-10 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2020-12-08 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2021-01-10 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-01-10 |
| HBQ | Instrument, Clip Removal | Neurology | Class 1 | 882.4200 | 2021-01-10 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2020-12-21 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2025-05-14 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2021-01-10 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2020-12-21 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2020-12-21 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2025-05-14 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2020-12-21 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| KBQ | Knife, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-01-10 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2020-12-08 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2021-01-10 |
| LDE | Stethoscope, Manual | Cardiovascular | Class 1 | 870.1875 | 2021-01-10 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-01-10 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2020-12-21 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2020-12-21 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2020-12-21 |
| GAE | Snare, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-01-10 |
| GFD | Dermatome | General, Plastic Surgery | Class 1 | 878.4820 | 2021-01-10 |
| HDK | Scissors, Episiotomy | Obstetrics/Gynecology | Class 1 | 884.4520 | 2021-01-10 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2021-01-10 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2025-05-12 |
| GWX | Fork, Tuning | Neurology | Class 1 | 882.1525 | 2021-01-10 |
| FMA | Depressor, Tongue, Non-Surgical | General Hospital | Class 1 | 880.6230 | 2020-12-21 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| HSO | Saw | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| GFC | Driver, Surgical, Pin | General, Plastic Surgery | Class 1 | 878.4820 | 2021-01-10 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-01-10 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-01-10 |
| LRZ | Screwdriver, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2021-01-10 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-10 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2021-01-10 |
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 |
| K953012 | Boston Surgical Products, Inc. | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | 1995-07-12 |
| 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 |
| K874057 | Myocure, Inc. | OPHTHALMIC TIP & BLADE SCALPELS | 1987-12-23 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0144-2024 | Covidien | 1 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 |
| Z-0168-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only |
| Z-0169-2024 | Covidien | 1 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only |
| Z-0039-2018 | Teleflex Medical | 1 | Pilling Knife Handles:
a) REF 352950
b) REF 352953
c) REF 352951
d) REF 352957
e) REF 352952 :
Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004571672 | Fischer Surgical Inc. | Imperial, MO, US |
| 2431166 | Sklar Corporation | West Chester, PA, US |
| 3015895045 | Sklar Corporation - Warehouse | Salisbury, MD, US |
| 3009718267 | DIVERSITY CORPORATION FZE | Sharjah Ash Shariqah, AE |
| 3004168759 | CENTRAL SURGICAL CO. PVT. LTD. | Sialkot Punjab, PK |
3013784566 when referencing this establishment in official correspondence.