FDA Device Registration & Listing · Tuttlingen Baden-Wurttemberg, DE · Registration 3013497507
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 |
|---|---|---|---|---|---|
| KAN | Chisel, Nasal | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| GEJ | Carrier, Ligature | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2016-12-19 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2016-12-19 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2016-12-19 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| EMS | Curette, Periodontic | Dental | Class 1 | 872.4565 | 2016-12-20 |
| EXX | Probe, Rectal, Non-Powered | Gastroenterology, Urology | Class 1 | 876.4730 | 2016-12-19 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2020-11-16 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-12-19 |
| JYH | Excavator, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2016-12-19 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| JZD | Snare, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2016-12-19 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2016-12-19 |
| JZY | Knife, Laryngeal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| HTO | Reamer | Orthopedic | Class 1 | 888.4540 | 2016-12-20 |
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| HRX | Arthroscope | Orthopedic | Class 2 | 888.1100 | 2024-12-19 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| JYZ | Rod, Measuring Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| EMO | Knife, Periodontic | Dental | Class 1 | 872.4565 | 2016-12-20 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-20 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2016-12-20 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2016-12-19 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2016-12-20 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2016-12-19 |
| GBX | Catheter, Irrigation | General, Plastic Surgery | Class 1 | 878.4200 | 2016-12-19 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2016-12-19 |
| KBQ | Knife, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-12-19 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| HXY | Brace, Drill | Orthopedic | Class 1 | 888.4540 | 2016-12-19 |
| HRT | Stripper, Surgical | Orthopedic | Class 1 | 888.4540 | 2016-12-19 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2016-12-19 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| FZQ | Clip, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4320 | 2016-12-19 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2016-12-19 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2016-07-21 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2016-12-19 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| GZX | Instrument, Microsurgical | Neurology | Class 1 | 882.4525 | 2016-12-19 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2016-12-19 |
| KBA | Rasp, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2016-12-19 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2016-12-19 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | Class 2 | 874.4760 | 2025-05-05 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3002862271 | Wenzler Medizintechnik GmbH | Frittlingen Baden-Wurttemberg, DE |
| 3022747125 | Stehle Medizintechnik | Renquishausen Baden-Wurttemberg, DE |
| 3003322138 | Kreidler Medizintechnik GmbH | Wurmlingen Baden-Wurttemberg, DE |
| 8010099 | MEDICON, E.G. | TUTTLINGEN Baden-Wurttemberg, DE |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K834189 | Imm Enterprises , Ltd. | JAKOBI SURG. INSTRUMENTS #7 44/47 | 1984-03-06 |
| K081051 | Spine View, Inc. | SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE | 2008-08-07 |
| K820777 | The Anspach Effort, Inc. | MINI-MICRO ARTHROSCOPIC SCAPEL | 1982-05-12 |
| K863293 | Lifestream Int'L, Inc. | DISPOSABLE SUCTION CANNULA NO. 902008-000 | 1986-09-09 |
| K874057 | Myocure, Inc. | OPHTHALMIC TIP & BLADE SCALPELS | 1987-12-23 |
| 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-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. |
| Z-0021-2015 | Biomet, Inc. | 1 | Compress Face Reamer
Product Usage:
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma. |
| Z-0041-05 | Linvatec Corp. | 2 | Ultra Power Burs, Sterile, Single-Use. |
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005809810 | Jarit GmbH | Rietheim-Weilheim Baden-Wurttemberg, DE |
| 2434839 | ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. | WESTBURY, NY, US |
| 3035708926 | MED2B LTD. | Kitzingen Bavaria, DE |
| 1219518 | HOLMED LLC | Attleboro, MA, US |
| 9611112 | HEBUMEDICAL GMBH | TUTTLINGEN Baden-Wurttemberg, DE |
3013497507 when referencing this establishment in official correspondence.