FDA Device Registration & Listing · Tuttlingen Baden-Wurttemberg, DE · Registration 3010726901
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2018-07-19 |
| KTG | Knife, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2015-04-23 |
| GEE | Brush, Biopsy, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2016-06-30 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2019-09-11 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-19 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| JYW | Press, Vein | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-19 |
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | Class 1 | 874.4140 | 2015-04-23 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2015-04-23 |
| GDZ | Handle, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-19 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| HRS | Plate, Fixation, Bone | Orthopedic | Class 2 | 888.3030 | 2019-09-11 |
| HKF | Mirror, Headband, Ophthalmic | Ophthalmic | Class 1 | 886.1500 | 2015-04-23 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2018-03-13 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-19 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2015-04-23 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| KBB | Rongeur, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2015-04-23 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| EBA | Light, Surgical Headlight | Dental | Class 1 | 872.4630 | 2015-04-23 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2015-04-23 |
| HBF | Drills, Burrs, Trephines & Accessories (Compound, Powered) | Neurology | Class 2 | 882.4305 | 2024-04-17 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2015-04-23 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| KAQ | Gouge, Nasal, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-19 |
| JYM | Inserter, Myringotomy Tube | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| JZF | Tube, Ear Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-19 |
| EMQ | Hoe, Periodontic | Dental | Class 1 | 872.4565 | 2018-07-19 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-19 |
| JYS | Perforator, Ear-Lobe | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| JYJ | Gauge, Measuring | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2015-04-23 |
| JYK | Holder, Ear Speculum | General, Plastic Surgery | Class 1 | 878.1800 | 2018-07-19 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2021-02-09 |
| NNR | Block, Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2015-04-23 |
| NNO | Jig, Piston Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2018-07-19 |
| KAK | Probe, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| EPY | Speculum, Ent | General, Plastic Surgery | Class 1 | 878.1800 | 2015-04-23 |
| KEW | Slides, Microscope | Pathology | Class 1 | 864.3010 | 2018-07-19 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-03-13 |
| MMO | Tray, Surgical, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2015-04-22 |
| KBH | Adenotome | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-19 |
| KAP | Curette, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-23 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9611814 | FRITZ HUBER GmbH & Co. KG | TUTTLINGEN Baden-Wurttemberg, DE |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K042598 | Zimmer, Inc. | PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES | 2004-10-29 |
| K190842 | Jiangsu Trauhui Medical Instrument Co., Ltd. | Comus Locking Plate systems | 2020-02-03 |
| K130510 | Arthrex, Inc. | ARTHREX COMPRESSION PLATES | 2013-09-25 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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-0034-2022 | Flower Orthopedics Corporation | 2 | Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 |
| Z-0007-2013 | Invuity, Inc. | 2 | BriteField illuminated Suction Device;
Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray.
The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. |
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1032347 | BIOMET MICROFIXATION | Jacksonville, FL, US |
| 2084346 | MARINA MEDICAL INSTRUMENTS, INC. | Davie, FL, US |
| 3023155873 | MAXMORESPINE | San Diego, CA, US |
| 3005440795 | XINHUA SURGICAL INSTRUMENT CO. LTD. | ZIBO Shandong, CN |
| 9610905 | KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, DE |
3010726901 when referencing this establishment in official correspondence.