FDA Device Registration & Listing · NEUHAUSEN OBECK Baden-Wurttemberg, DE · Registration 9616250
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 | 2001-12-11 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| HBT | Applier, Hemostatic Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| HNG | Rongeur, Lachrymal Sac | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2022-11-21 |
| HNP | Introducer, Sphere | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2022-11-21 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2023-05-27 |
| HXE | Fork | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2022-11-21 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2001-12-11 |
| KBD | Scissors, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-11-21 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2000-02-09 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-12-11 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-12-11 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2001-12-11 |
| FZQ | Clip, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4320 | 2022-11-21 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-05-27 |
| HXN | Applier, Cerclage | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| FGY | Cannula, Injection | General, Plastic Surgery | Class 1 | 878.4200 | 2022-11-21 |
| DYO | Band, Material, Orthodontic | Dental | Class 1 | 872.5410 | 2001-12-11 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2022-11-21 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2022-11-21 |
| KAY | Punch, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-11-21 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2022-11-21 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| EMH | Forceps, Rongeur, Surgical | Dental | Class 1 | 872.4565 | 2022-11-21 |
| HSO | Saw | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-11-21 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2001-12-11 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2023-05-27 |
| HNM | Needle, Ophthalmic Suturing | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| GDX | Scalpel, One-Piece | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| HLF | Device, Measuring, Lens Radius, Ophthalmic | Ophthalmic | Class 1 | 886.1430 | 2022-11-21 |
| KYG | Device, Irrigation, Ocular Surgery | Ophthalmic | Class 1 | 886.4360 | 2022-11-21 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| GAZ | Tubing, Noninvasive | General Hospital | Class 2 | 880.6740 | 2022-11-21 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | Class 1 | 880.6960 | 2001-12-11 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-12-11 |
| FFO | Retractor, Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2022-11-21 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2000-02-09 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| HNK | Probe, Trabeculotomy | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HOC | Clip, Iris Retractor | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2001-12-11 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2022-11-21 |
| HGC | Clamp, Uterine | Obstetrics/Gynecology | Class 1 | 884.4520 | 2022-11-21 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| HNY | Cystotome | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HNA | Spud, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HMR | Marker, Ocular | Ophthalmic | Class 1 | 886.4570 | 2022-11-21 |
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | Class 1 | 886.4335 | 2023-05-27 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2022-11-21 |
| HLN | Gauge, Lens, Ophthalmic | Ophthalmic | Class 1 | 886.1420 | 2022-11-21 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2001-12-11 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2001-12-11 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | General Hospital | Class 1 | 880.6025 | 2022-11-21 |
| LRZ | Screwdriver, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-05-27 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| HNX | Depressor, Orbital | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2022-11-21 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2023-05-27 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2001-12-11 |
| HMZ | Trabeculotome | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2000-02-09 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2023-05-27 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2022-11-21 |
| HYA | Forceps, Wire Holding | General, Plastic Surgery | Class 1 | 878.4800 | 2022-11-21 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2022-11-21 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2022-11-21 |
| HMQ | Marker, Sclera | Ophthalmic | Class 1 | 886.4570 | 2022-11-21 |
| FSP | Loupe, Diagnostic/Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2001-12-11 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2023-05-27 |
No official correspondent registered.
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K922626 | Andronic Devices, Ltd. | ADEPT INSTRUMENT POSITIONING ACCESSORY | 1992-10-19 |
| K820290 | The Anspach Effort, Inc. | SELF RETAINING RETRACTOR FOR HAND SURG | 1982-03-05 |
| K760422 | Cutter Laboratories, Inc. | SURGICAL RETRACTOR | 1976-08-23 |
| K854401 | Microsurgical Technology, Inc. | THE NEW MOBILE TIP MCINTYRE CANNULA | 1985-12-30 |
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0031-05 | N/A | 1 | Hem-o-lok Endo5 Ligation Applier |
| 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-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0019-2023 | Hobbs Medical, Inc. | 1 | Hobbs Scope Introducer
Catalog Number: 4650 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9610612 | AESCULAP AG | TUTTLINGEN, DONAU Baden-Wurttemberg, DE |
| 3003244954 | ZEPF MEDICAL INSTRUMENTS GMBH | SEITINGEN-OBERFLACHT 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 |
9616250 when referencing this establishment in official correspondence.