FDA Device Registration & Listing · SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE · Registration 3003244954
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2001-05-01 |
| LWK | Razor, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-05-01 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| JXX | Forceps, Wire Closure, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2001-04-23 |
| GAE | Snare, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-05-01 |
| KAQ | Gouge, Nasal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| KBO | Guillotine, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| GXJ | Punch, Skull | Neurology | Class 1 | 882.4750 | 2001-05-01 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| EMR | File, Periodontic | Dental | Class 1 | 872.4565 | 2001-04-23 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | Class 1 | 878.4820 | 2001-05-01 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2001-04-23 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2001-05-15 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2001-04-23 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| HXI | Passer, Wire, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2001-05-01 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2001-04-23 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2001-04-23 |
| EKI | Carrier, Amalgam, Operative | Dental | Class 1 | 872.4565 | 2001-04-23 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| GAI | Stripper, Vein, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2001-05-01 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2001-04-23 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-01 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| KBH | Adenotome | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| KDC | Instrument, Surgical, Disposable | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2001-05-14 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| JZD | Snare, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| ECS | Pusher, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2001-04-23 |
| HPN | Magnet, Permanent | Ophthalmic | Class 1 | 886.4445 | 2001-05-01 |
| JYR | Nipper, Malleus | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-01 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-01 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2001-04-23 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2001-05-01 |
| HHM | Sound, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2001-05-14 |
| HXN | Applier, Cerclage | Orthopedic | Class 1 | 888.4540 | 2001-04-23 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2001-05-01 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| KCP | Syringe, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2001-05-01 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-05-14 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2001-04-23 |
| EPE | Brush, Cleaning, Tracheal Tube | Anesthesiology | Class 1 | 868.5795 | 2001-05-01 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2001-05-01 |
| JYF | Clamp, Ossicle Holding | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2001-04-23 |
| JZE | Spoon, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| KBZ | Snare, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-01 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2001-04-23 |
| KCI | Trocar, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-01 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2001-05-01 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2001-05-01 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2001-05-01 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2001-04-23 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2001-04-23 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2001-04-23 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| EFK | Forceps, Articulation Paper | Dental | Class 1 | 872.4565 | 2001-04-23 |
| EJG | Forceps, Rubber Dam Clamp | Dental | Class 1 | 872.6300 | 2001-05-14 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2001-04-23 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| GFD | Dermatome | General, Plastic Surgery | Class 1 | 878.4820 | 2001-04-23 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2001-04-23 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2001-05-01 |
| LGH | Instrument, Cast Removal, Ac-Powered | Orthopedic | Class 1 | 888.5960 | 2001-05-15 |
| KDG | Chisel (Osteotome) | General, Plastic Surgery | Class 1 | 878.4820 | 2001-04-23 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2001-05-01 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2001-04-23 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Anesthesiology | Class 1 | 868.5640 | 2001-05-01 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| KBE | Snare, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-01 |
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2001-04-23 |
| JYP | Knife, Myringotomy | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-04-23 |
| KBR | Needle, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-01 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2001-05-14 |
| JBS | Timer, General Laboratory | Clinical Chemistry | Class 1 | 862.2050 | 2001-04-23 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2001-04-23 |
| EKG | Condenser, Amalgam And Foil, Operative | Dental | Class 1 | 872.4565 | 2001-04-23 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-04-23 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2001-05-14 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2001-05-01 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2001-05-01 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2001-04-23 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2001-04-23 |
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | Class 1 | 878.5910 | 2001-05-01 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-01 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2001-04-23 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2001-04-23 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2001-04-23 |
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | Class 1 | 886.4350 | 2001-05-01 |
| KBG | Trocar, Sinus | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-15 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-05-14 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2001-04-23 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K905383 | Micro Surgical Instruments Corp. | 2710-000 OSCILLATING SAW, GENERAL ASSEMBLY | 1991-06-18 |
| K913369 | Micro Surgical Instruments Corp. | MICRO-AIRE MODEL 2060 | 1991-11-01 |
| K874057 | Myocure, Inc. | OPHTHALMIC TIP & BLADE SCALPELS | 1987-12-23 |
| K831798 | I M, Inc. | DISPOSABLE SCALPELS | 1983-07-19 |
| K914226 | E.I. Dupont DE Nemours & Co., Inc. | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | 1991-11-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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. |
| Z-1922-2024 | Alcon Research LLC Aspex Facility | 1 | 20 Gauge V-Lance Knife
Model/Catalog Number: 8065912001
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-1923-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model/Catalog Number: 8065921541
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Z-1924-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut S Safety Sideport Knife 1.0mm Dual Bevel
Model/Catalog Number: 8065771540
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Z-1925-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut S Safety Sideport Knife 1.2mm Dual Bevel
Model/Catalog Number: 8065771541
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9610612 | AESCULAP AG | TUTTLINGEN, DONAU Baden-Wurttemberg, DE |
| 9616250 | ASANUS MEDIZINTECHNIK GMBH | NEUHAUSEN OBECK Baden-Wurttemberg, DE |
| 9710524 | ULTIMATE MEDICAL PRODUCTS LTD. | SHARJAH Ash Shariqah, AE |
| 3003807268 | HIVE INTERNATIONAL PVT LTD. | Sialkot Punjab, PK |
| 3003644849 | DR. FRIGZ INTERNATIONAL (PVT) LTD. | SIALKOT, Punjab, PK |
3003244954 when referencing this establishment in official correspondence.