FDA Device Registration & Listing · LIPTINGEN Baden-Wurttemberg, DE · Registration 9611502
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 1995-01-03 |
| HOE | Caliper, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| EIR | Scissors, Collar And Crown | Dental | Class 1 | 872.4565 | 1978-03-21 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2018-06-11 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2007-11-30 |
| HNN | Knife, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 1978-03-21 |
| FHQ | Holder, Needle, Gastroenterologic | Gastroenterology, Urology | Class 1 | 876.4730 | 1995-02-14 |
| HMR | Marker, Ocular | Ophthalmic | Class 1 | 886.4570 | 1995-02-14 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2007-12-12 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| HNB | Spoon, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 1978-03-21 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | Class 1 | 886.4350 | 2025-12-15 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2023-03-08 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2020-04-15 |
| HOD | Clamp, Eyelid, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 1978-03-21 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 1995-02-14 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 1978-03-21 |
| HPN | Magnet, Permanent | Ophthalmic | Class 1 | 886.4445 | 1978-03-21 |
| HNJ | Punch, Corneo-Scleral | Ophthalmic | Class 1 | 886.4350 | 1995-02-14 |
| JZB | Scissors, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 1978-03-21 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K854401 | Microsurgical Technology, Inc. | THE NEW MOBILE TIP MCINTYRE CANNULA | 1985-12-30 |
| K874057 | Myocure, Inc. | OPHTHALMIC TIP & BLADE SCALPELS | 1987-12-23 |
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 |
| K871646 | Ocular Instruments, Inc. | TANNE CORNEAL CUTTING BLOCK | 1987-05-18 |
| K914226 | E.I. Dupont DE Nemours & Co., Inc. | ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK | 1991-11-19 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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. |
| Z-0026-04 | Surgical Specialties Corp | 1 | Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. |
| Z-1922-2024 | Alcon Research LLC Aspex Facility | 1 | 20 Gauge V-Lance Knife
Model/Catalog Number: 8065912001
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-1923-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model/Catalog Number: 8065921541
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3034992373 | PLU OPHTHALMIC Corp | Coral Gables, FL, US |
| 3031572059 | TissueGUARD | Dresden Saxony, DE |
| 3008754084 | Belle Healthcare Technology Co., Ltd. | Suzhou Jiangsu, CN |
| 3008719017 | SUMMIT MEDICAL LLC | Saint Paul, MN, US |
| 3012494290 | SANICURE BV | SCHIPHOL Noord-Holland, NL |
9611502 when referencing this establishment in official correspondence.