Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 31
- Latest Decision
- 1977-11-09
Clearances · page 48 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K771914 | SUBJECTIVE REFRACTOR, MOSEL SR-111 | American Optical Corp. | HKO | Class I | 1977-11-09 |
| K771900 | 71110 DESK CHARGER | Welch Allyn, Inc. | HLS | Class I | 1977-11-09 |
| K772044 | TECHSIGHT LENSES WITH ZUMA COATING | Techsight Corp. | HQG | Class I | 1977-11-09 |
| K771866 | TROUTMAN CORNEAL PUNCH | Edward Weck, Inc. | HRH | Class I | 1977-11-09 |
| K772024 | RX LENS SERIES | Gentex Corporation | HQG | Class I | 1977-11-09 |
| K771711 | BIOTOME | Berkeley Bio-Engineering | HQE | Class II | 1977-09-28 |
| K771644 | FRAGMATOME MODEL 820 | Berkeley Bio-Engineering | HQC | Class II | 1977-09-26 |
| K771416 | IRRIGATION/ASPIRATION NEEDLE | Concept, Inc. | HMX | Class I | 1977-09-12 |
| K771189 | HOT TEMP CAUTERY | Edward Weck, Inc. | HQP | Class II | 1977-07-11 |
| K771003 | LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS | Edward Weck, Inc. | HNR | Class I | 1977-06-17 |
| K770955 | MIRACLELENS | M.R.M. Optics, Inc. | HQG | Class I | 1977-06-17 |
| K770888 | POMERANTZEFF EQUATOR PLUS CAMERA | Medical Instrument Research Assoc., Inc. | HKI | Class II | 1977-06-03 |
| K770768 | OPHTHALMOSCOPE, MODEL #11100 | Welch Allyn, Inc. | HLI | Class II | 1977-05-06 |
| K770389 | LENS SET, MENTOR TRIAL | Codman & Shurtleff, Inc. | HPC | Class I | 1977-03-14 |
| K770221 | MEMLITE (PLASTIC EYEGLASS FRAMES) | American Optical Corp. | HQZ | Class I | 1977-02-17 |
| K770222 | IRIS RETRACTOR | Concept, Inc. | HNI | Class I | 1977-02-17 |
| K770194 | NASO-LACRIMAL DUCT INSERT | Concept, Inc. | HNL | Class I | 1977-02-14 |
| K770101 | SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK | Edward Weck, Inc. | HNR | Class I | 1977-01-25 |
| K770103 | HOOK, IRIS, SHEPARD U-SHAPED | Edward Weck, Inc. | HNQ | Class I | 1977-01-25 |
| K770105 | SHEPARD II, LENS FORCEP W/ LOCK | Edward Weck, Inc. | HNR | Class I | 1977-01-25 |
| K770104 | BINKHORST LENS FORCEPS W/OUT IRRIGATOR | Edward Weck, Inc. | HNR | Class I | 1977-01-24 |
| K770099 | SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK | Edward Weck, Inc. | HNR | Class I | 1977-01-24 |
| K770097 | HERSHMAN LENS FORCEPS WITH IRRIGATOR | Edward Weck, Inc. | HNR | Class I | 1977-01-24 |
| K770102 | HERSHMAN LENS FORCEPS W/OUT IRRIGATOR | Edward Weck, Inc. | HNR | Class I | 1977-01-24 |
| K770098 | HOOK, IRIS, HERSHMAN | Edward Weck, Inc. | HNQ | Class I | 1977-01-24 |
| K770100 | BINKHORST LENS FORCEP W/ IRRIGATOR | Edward Weck, Inc. | HNR | Class I | 1977-01-24 |
| K770040 | SCISSORS, STRABIMUS, 4 STRAIGHT | J. Sklar Mfg. Co., Inc. | HNF | Class I | 1977-01-14 |
| K770041 | SCISSORS, STRABISMUS, 4 CURVED | J. Sklar Mfg. Co., Inc. | HNF | Class I | 1977-01-14 |
| K770019 | SCISSORS, IRIS | J. Sklar Mfg. Co., Inc. | HNF | Class I | 1977-01-12 |
| K761353 | VITEROUS SUCTION CUTTER | Concept, Inc. | HKP | Class II | 1977-01-05 |
| K761251 | WECK TYING FORCEP, STRAIGHT TITANIUM | Edward Weck, Inc. | HNR | Class I | 1976-12-16 |
| K761215 | F4912 NIGHT VISION AID | Itt Corp. | HPG | Class I | 1976-12-16 |
| K761163 | AD7 PLASTIC MULTIFOCAL EYEGLASS LENS | American Optical Corp. | HQG | Class I | 1976-12-16 |
| K761252 | WECK TYING FORCEP, CURVED TITANIUM | Edward Weck, Inc. | HNR | Class I | 1976-12-16 |
| K761253 | CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM | Edward Weck, Inc. | HND | Class I | 1976-12-16 |
| K761155 | CELLULOSE EYE STICK | Winn Hirsch & Assoc. | HOZ | Class II | 1976-12-16 |
| K760949 | CHARLES IRRIGATING FUNDUS CONTACT LENS | Richard'S Medical Equip., Inc. | HJI | Class I | 1976-11-11 |
| K760849 | FELDSTEIN BLEPHAROSTOMY CLIP SQUARE | V. Mueller O.V. Baxter Healthcare Corp. | HNC | Class I | 1976-11-02 |
| K760848 | FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU | V. Mueller O.V. Baxter Healthcare Corp. | HNC | Class I | 1976-11-02 |
| K760697 | EVANS ARM AND HAND REST | Alcon Laboratories | HRK | Class I | 1976-11-02 |
| K760847 | FELDSTEIN BLEPHAROPLASTY CLIP SHARP P | V. Mueller O.V. Baxter Healthcare Corp. | HNC | Class I | 1976-11-02 |
| K760820 | NALGENE EMERGENCY EYE WASH | Nagle Co. | KYG | Class I | 1976-10-20 |
| K760771 | SOLA SCHULTZE-CROCK OPTHALMOSCOPE | Codman & Shurtleff, Inc. | HLJ | Class II | 1976-10-15 |
| K760770 | SOLA COMMIDO LOUPE | Codman & Shurtleff, Inc. | HLJ | Class II | 1976-10-15 |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Medical Instrument Research Assoc., Inc. | HQJ | Class II | 1976-10-05 |
| K760684 | VISC X-VITREOUS ASPIRATING & CUT. INSTR | Varian Assoc., Inc. | HKP | Class II | 1976-10-05 |
| K760726 | ELECTRO-KERATOTOME, LINE-OPERATED | Storz Instrument Co. | HNO | Class I | 1976-10-05 |
| K760444 | PHOTOCOAGULATOR, LOG 3 PORTABLE XENON | Varian Assoc., Inc. | HQB | Class II | 1976-08-26 |
| K760187 | KNIFE, TROUTMAN CORNEAL SMALL | V. Mueller O.V. Baxter Healthcare Corp. | HNN | Class I | 1976-08-04 |
| K760188 | SCISSORS, MICRO IRIS CURVED | V. Mueller O.V. Baxter Healthcare Corp. | HNF | Class I | 1976-08-04 |
| K760326 | SURGICAL INSTRUMENTS, OPTHALMIC | Depuy, Inc. | HNF | Class I | 1976-08-04 |
| K760190 | SCISSORS, IRIS STRAIGHT | V. Mueller O.V. Baxter Healthcare Corp. | HNF | Class I | 1976-08-04 |
| K760199 | ELECTRORETINOGRAPH | Lkc Technologies, Inc. | HLZ | Class II | 1976-08-04 |
| K760186 | DISSECTOR, TROUTMAN CORNEAL | V. Mueller O.V. Baxter Healthcare Corp. | HNN | Class I | 1976-08-04 |
| K760185 | SCISSORS, MICRO IRIS STRAIGHT | V. Mueller O.V. Baxter Healthcare Corp. | HNF | Class I | 1976-08-04 |
| K760191 | KNIFE, TROUTMAN CORNEAL LARGE | V. Mueller O.V. Baxter Healthcare Corp. | HNN | Class I | 1976-08-04 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.