FDA Device Registration & Listing · Wurmlingen Baden-Wurttemberg, DE · Registration 3033536312
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 |
|---|---|---|---|---|---|
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-11-04 |
| HWK | Trephine | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| HCZ | Forceps, Surgical, Gynecological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2024-11-04 |
| DRB | Stylet, Catheter | Cardiovascular | Class 2 | 870.1380 | 2024-11-04 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2024-11-04 |
| HDJ | Scissors, Umbilical | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-11-04 |
| FZQ | Clip, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4320 | 2024-11-04 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2024-11-04 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| GAH | Stylet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| HBQ | Instrument, Clip Removal | Neurology | Class 1 | 882.4200 | 2024-11-04 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-11-04 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2024-11-04 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2024-11-04 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| HST | Apparatus, Traction, Non-Powered | Orthopedic | Class 1 | 888.5850 | 2024-11-04 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-10-11 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2024-11-04 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2024-11-04 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HWQ | Passer | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-11-04 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| GCB | Needle, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2024-11-04 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| KGZ | Accessories, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2024-11-04 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-11-04 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| GDG | Hook, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| DWX | Stripper, Artery, Intraluminal | Cardiovascular | Class 2 | 870.4875 | 2024-11-04 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2024-11-04 |
| FNS | Ring Cutter | General Hospital | Class 1 | 880.6200 | 2024-11-04 |
| JEK | Forceps, Biopsy, Bronchoscope (Rigid) | Ear, Nose, Throat | Class 2 | 874.4680 | 2024-11-04 |
| JYK | Holder, Ear Speculum | General, Plastic Surgery | Class 1 | 878.1800 | 2024-11-04 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| GEJ | Carrier, Ligature | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2024-11-04 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2024-11-04 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-11-04 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| HTP | File | Orthopedic | Class 1 | 888.4540 | 2024-11-04 |
| GFI | Osteotome, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2024-11-04 |
| 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 |
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| K223112 | Smith & Nephew, Inc. | MAVERICK Mini External Fixation System | 2022-12-08 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0027-2016 | Zimmer, Inc. | 1 | Zimmer Universal Locking System, Titanium 3.5mm.
Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices. |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0010-2008 | N/A | 1 | EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758. |
| 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 |
|---|---|---|
| 3019455 | ORTHO-MED, INC. | Tigard, OR, US |
| 9611283 | DIMEDA INSTRUMENTE GMBH | TUTTLINGEN Baden-Wurttemberg, DE |
| 9610612 | AESCULAP AG | TUTTLINGEN, DONAU Baden-Wurttemberg, DE |
| 3022320321 | ALIRA MEDICAL DEVICES LLC | Rancho Cucamonga, CA, US |
| 2916714 | AESCULAP, INC. | CENTER VALLEY, PA, US |
3033536312 when referencing this establishment in official correspondence.