FDA Device Registration & Listing · Tuttlingen Baden-Wurttemberg, DE · Registration 3015451162
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 |
|---|---|---|---|---|---|
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2019-11-06 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-04-21 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2020-10-19 |
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2019-11-19 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2019-05-28 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2020-05-28 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2019-12-03 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2019-12-16 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2023-10-20 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2019-06-11 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-21 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2021-03-08 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2020-02-03 |
| FGN | Retractor, Non-Self-Retaining | Gastroenterology, Urology | Class 1 | 876.4730 | 2020-01-22 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2019-07-12 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-12-16 |
| KBQ | Knife, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-07-22 |
| HNI | Retractor, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2019-12-16 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-10-19 |
| HXD | Clamp | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-12 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2019-06-11 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2020-02-13 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2019-11-28 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2020-03-06 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2020-05-13 |
| HXL | Mallet | General, Plastic Surgery | Class 1 | 878.4800 | 2023-05-09 |
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2021-12-10 |
| LRC | Instrument, Ent Manual Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-10-11 |
| HRQ | Hemostat | General, Plastic Surgery | Class 1 | 878.4800 | 2021-03-17 |
| KBL | Depressor, Metal Tongue, Surgical | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-07-25 |
| LRW | Scissors, General, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2021-01-21 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2020-10-19 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2021-03-17 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2020-05-19 |
| JYG | Curette, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-07-22 |
| KAL | Retractor, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-06-28 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2019-12-04 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 2019-10-11 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2019-05-28 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2021-04-08 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2019-07-12 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2022-02-01 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2020-04-07 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2020-06-23 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2019-07-26 |
| KAI | Mirror, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2025-07-15 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2023-12-27 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2019-09-05 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K953012 | Boston Surgical Products, Inc. | DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS | 1995-07-12 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| K854401 | Microsurgical Technology, Inc. | THE NEW MOBILE TIP MCINTYRE CANNULA | 1985-12-30 |
| K143738 | Intuit Medical Products, LLC | DSS Sinusplasty Balloon Catheter | 2015-08-27 |
| 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-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-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0011-2019 | Ellex iScience, Inc. | 1 | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. |
| Z-0022-2009 | Becton Dickinson and Company | 1 | BD Visitec High Viscosity Injector, 4mm
Ref: 585173. The product is intended for Vitroretinal Surgery. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1424263 | Isomedix Operations, Inc. | Libertyville, IL, US |
| 1643817 | ISOMEDIX OPERATIONS INC | EL PASO, TX, US |
| 3014334038 | Integra LifeSciences Production Corporation | Mansfield, MA, US |
| 3012185136 | RUMEX Baltics SIA | Riga, LV |
| 1412854 | ELMED, INC. | Glendale Heights, IL, US |
3015451162 when referencing this establishment in official correspondence.