FDA Device Registration & Listing · BALGHEIM Baden-Wurttemberg, DE · Registration 3003435550
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 |
|---|---|---|---|---|---|
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2017-10-17 |
| JZY | Knife, Laryngeal | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-01-19 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2003-01-31 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2024-03-16 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2017-04-06 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2003-01-31 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2025-04-21 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-01-17 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2003-01-31 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2024-04-28 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2003-01-31 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2026-05-13 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2025-01-22 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-02-22 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-17 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2003-01-31 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2013-06-13 |
| HAO | Instrument, Surgical, Non-Powered | Neurology | Class 1 | 882.4535 | 2013-01-28 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-09-02 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2003-01-31 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-08-26 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2023-03-31 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2023-10-18 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2022-04-13 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | Obstetrics/Gynecology | Class 1 | 884.4530 | 2023-07-07 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2025-05-12 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2003-01-31 |
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-31 |
| JYH | Excavator, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2017-06-08 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-01-28 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2018-01-27 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2025-11-23 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-17 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2023-10-23 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2024-03-16 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2022-04-11 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2023-10-30 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2025-12-03 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2024-03-16 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2003-01-31 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-06-13 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2024-11-18 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K874057 | Myocure, Inc. | OPHTHALMIC TIP & BLADE SCALPELS | 1987-12-23 |
| K143738 | Intuit Medical Products, LLC | DSS Sinusplasty Balloon Catheter | 2015-08-27 |
| 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 |
| 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-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-0026-04 | Surgical Specialties Corp | 1 | Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8010155 | A.HANDTE MEDIZINTECHNIK GMBH & CO. KG | TUTTLINGEN Baden-Wurttemberg, DE |
| 3043355002 | PILOTIS TECH LLC | Brookhaven, GA, US |
| 3014967149 | GLW, Inc. | Englewood Cliffs, NJ, US |
| 3014334038 | Integra LifeSciences Production Corporation | Mansfield, MA, US |
| 1417592 | MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, US |
3003435550 when referencing this establishment in official correspondence.