Panels › Ophthalmic › Product code HNO · Class 1
Keratome, Ac-Powered
Regulation 886.4370
0510(k)s in 12 months (83 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in HNO
| Company | 510(k)s | Recalls |
|---|---|---|
| Bausch & Lomb, Inc. | 4 | 4 |
| Med-Logics, Inc. | 7 | 1 |
| Millennium Biomedical, Inc. | 5 | 0 |
| Oasis Medical, Inc. | 5 | 0 |
| Micro Specialties, Inc. | 4 | 0 |
| Moria SA | 4 | 0 |
| Surgin Surgical Instrumentation, Inc. | 4 | 0 |
| AMO Manufacturing USA, LLC | 0 | 3 |
| Howard Instruments, Inc. | 3 | 0 |
| Lasersight Technologies, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2000 | K990227 | ULTRASHAPER KERATOME Lasersight Technologies, Inc. | HNO |
| Nov 16, 1999 | K992978 | RICROKERATOME BLADE Surgistar, Inc. | HNO |
| Sep 24, 1999 | K990900 | MICROKERATOME, MODEL MK-2000 Nidek, Inc. | HNO |
| Apr 28, 1999 | K984540 | KERAVISION VACUUM RING SYSTEM Keravision, Inc. | HNO |
| Dec 22, 1998 | K981554 | MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) Micra Instruments , Ltd., GB | HNO |
| Dec 22, 1998 | K980675 | SUMMIT KRUMEICH-BARRAQUER MICROKERATOME Summit Technology, Inc. | HNO |
| Dec 2, 1998 | K983317 | BARRON MICROKERATOME SYSTEM, MODEL B2000 Barron Precision Instruments, LLC | HNO |
| Aug 25, 1998 | K981742 | ONE UP DISPOSABLE KERATOME HEAD Moria, Inc., FR | HNO |
| Aug 14, 1998 | K981155 | FLAPMAKER DISPOSABLE MICROKERATOME Hawken Industries | HNO |
| Jul 23, 1998 | K981071 | ML MICROKERATOME Med-Logics, Inc. | HNO |
| May 1, 1998 | K980985 | SCMD-1000 Howard Instruments, Inc. | HNO |
| May 1, 1998 | K980510 | KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) Micro Specialties, Inc. | HNO |
| May 1, 1998 | K980508 | KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 Micro Specialties, Inc. | HNO |
| Apr 22, 1998 | K974598 | MICROKERATOME OR THE MATE Howard Instruments, Inc. | HNO |
| Apr 15, 1998 | K980924 | PLANCON MICROLAMELLAR KERATOME EVOLUTION Plancon Instruments, FR | HNO |
| Jan 8, 1998 | K974004 | AUTOMATED DISPOSABLE KERATOME (ADK) Lasersight Technologies, Inc. | HNO |
| Oct 24, 1997 | K972808 | HANSATOME MICROKERATOME Chiron Vision Corp. | HNO |
| Oct 10, 1997 | K972727 | CBALK-1000 BLADE Howard Instruments, Inc. | HNO |
| Oct 3, 1997 | K973294 | INNOVATOME MICROKERATOME Innovative Optics, Inc. | HNO |
| Mar 31, 1997 | K970377 | PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES) Plancon Instruments, FR | HNO |
| Dec 9, 1996 | K962661 | ML MICROKERATOME BLADE Med-Logics, Inc. | HNO |
| Apr 26, 1996 | K960395 | PLANCON MIRCOLAMELLAR KERATOME Plancon Instruments, FR | HNO |
| Nov 6, 1995 | K954058 | BARRAQUER-KRUMEICH REFRACTIVE SET Eyetech M.V.A., DE | HNO |
| Nov 22, 1994 | K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT Chiron Vision Corp. | HNO |
| Apr 1, 1994 | K935342 | SCMD KERATOME S.C.M.D. Keratomes of Arizona | HNO |
| Nov 5, 1991 | K913697 | AUTOMATIC CORNEAL SHAPER Hansa Research & Development, Inc. | HNO |
| May 22, 1991 | K911062 | QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY Storz Instrument Co. | HNO |
| Jan 22, 1991 | K904845 | STORZ DRAEGER ROTOR KERATOME Storz Instrument Co. | HNO |
| Oct 17, 1990 | K903912 | KERATOME Micro Precision Instrument Co. | HNO |
| May 29, 1987 | K870807 | BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE Allergan, Inc. | HNO |
| Dec 15, 1986 | K864065 | BKS-42 DISPOSABLE VACUUM TUBING PACK Allergan, Inc. | HNO |
| Feb 4, 1986 | K860001 | BARRAQUER-KRUMEICH REFRACTIVE SET American Medical Optics | HNO |
| Oct 5, 1976 | K760726 | ELECTRO-KERATOTOME, LINE-OPERATED Storz Instrument Co. | HNO |
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