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Ophthalmic

4,750 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS (K854225)Advanced Medical Technology, Inc.1985-12-27
PLACIDO DISC (K854054)Cutler Medical Instruments1985-12-27
PHACO PACKS, 1A PACKS & PACK COMPONENTS (K854116)Medical Corp. of America1985-12-27
O.M.S. ULTRA-PHACO (K844373)Optical Micro Systems, Inc.1985-12-19
STORZ IAS DISPOSABLE PACK (K853430)Storz Instrument Co.1985-12-16
IN-HOME VISION MONITORING KIT (K854047)Rich-Larky Company, Inc.1985-12-13
700-123 EYE SHADE (K853043)Health Saver Products1985-12-13
HESSBURG LIGHT GUARD (K853035)Visitec Co.1985-12-13
VISITEC OPHTHALMIC ASPIRATION UNIT MODEL 100 (K853961)Visitec Co.1985-12-13
IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM (K854330)Par Technology Park1985-12-13
PY-RITE (K853758)Golden Dental Products, Inc.1985-12-03
THE NEW MCINTYRE CANNULA (K853777)Microsurgical Technology, Inc.1985-11-21
OPHTHALMIC LASER PHOTOCOAGULATOR (K853890)Mira, Inc.1985-11-12
SIOM (K854343)South West Intl., Inc.1985-11-12
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE (K854244)Keeler Instruments, Inc.1985-11-12
THE ULTRA-MATE LENS (K854218)Optical Systems Intl., Inc.1985-11-12
KERATOLUX (K854383)Carl Zeiss, Inc.1985-11-12
OPHALMIC LASER PHOTOCOAGULATOR (K854288)Mira, Inc.1985-11-12
TECHNA VISION AUTO-PERIMETER (K853290)Techna Vision1985-11-12
SUNGLASSES/OPTICAL FRAMES (K854264)Wha Chun Industries, Co., Ltd.1985-11-12
OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE (K853598)Myocure, Inc.1985-11-04
VERSABLADE (K852706)Alphamedix, Inc.1985-11-04
BEAVER R-K KNIFE (K852828)Rudolph Beaver, Inc.1985-11-04
STORZ DIAMOND KNIFE (K853403)Storz Instrument Co.1985-11-04
SMARTKNIFE SYSTEM (K853063)CooperVision, Inc.1985-11-04
VERSABLADE (K852633)Alphamedix, Inc.1985-11-04
MENTOR BRIGHTNESS ACUITY TESTER (K853736)Mentor O & O, Inc.1985-11-01
LASER IRAS (K853556)Randwal Instrument Co., Inc.1985-11-01
PHOTRON NEUROVISUAL STIMULATOR(MODIFICATION) (K853812)Biosan Laboratories, Inc.1985-11-01
VISTECH VCTS GLARE TESTER (K853481)Vistech Consultants, Inc.1985-10-29
TECHNA VISION, INC. ELECTRIC CHAIR (K853743)Techna Vision1985-10-17
TECHNA VISION, INC.ELECTRIC TABLE (K853744)Techna Vision1985-10-17
ALL KINDS OF SUNGLASSES (K853921)Winsburn Company , Ltd.1985-10-15
ORC ORACLE (K853668)Optical Radiation Corp.1985-10-15
ZEISS OPERATING KERATOMETER (K853723)Carl Zeiss, Inc.1985-10-15
THE FIELDMASTER MODEL 275 (K852936)Synemed, Inc.1985-10-15
COBURN I/A SYSTEM (K853457)Coburn Optical Ind., Inc.1985-10-15
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR (K853883)Medical Corp. of America1985-10-08
LASERSAFE EYE SHIELDS (K852404)Lasersafe, Inc.1985-10-04
RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (K853358)Dentsply Intl.1985-10-04
KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 (K853308)Frigitronics of Connecticut, Inc.1985-10-04
INDIRECT OPHTHALMOSCOPE (K853891)Carl Zeiss, Inc.1985-10-04
MAID MENTOR ASPIRATION/IRRIGATION DEVRO (K853382)Mentor O & O, Inc.1985-10-04
BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER (K853790)Rocky Mountain Medical Corp.1985-10-04
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES (K852529)Visitec Co.1985-09-24
CREAT BRAND I/A PACK CREAT BRAND PHACO PACK (K853189)Aesthetech Corp.1985-09-24
RELIANCE 1379 (K853359)Dentsply Intl.1985-09-24
MICRON-SCOPE (K853499)Magnum Diamond, Inc.1985-09-24
HUMPHREY FIELD ANALYZER MODEL 630 (K852639)Zeiss Humphrey System1985-09-18
ACUFEX COMPARATIVE SURGICAL KERATOMETER (K852424)Acufex Microsurgical, Inc.1985-09-11
VISITEC IRRIGATION CONTROL SYSTEM (K853243)Visitec Co.1985-09-11
MARLIN SOFT LENS HANDLER (K850984)Marlin Industries1985-09-10
MARLIN SOFT LENS TWEEZER (K850983)Marlin Industries1985-09-10
#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD (K852953)Design Med. Corp.1985-09-06
RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (K853149)F. & F. Koenigkramer1985-09-05
RELIANCE 6100 (K853150)F. & F. Koenigkramer1985-09-05
CONTACT LENS LOUPE, INSPETION LOUPE (K852054)Ascon Medical Instruments, Ltd.1985-09-05
RELIANCE 5000 (K853151)F. & F. Koenigkramer1985-09-05
ASCON OPHTHALMIC SPONGE (K852055)Ascon Medical Instruments, Ltd.1985-09-04
SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT (K852386)Barnes-Hind, Inc.1985-09-04
O.M.S. UV-COLOURS (K851410)Optical Moulding Systems1985-08-27
OMS/GONVERS RETINAL PERFORATOR (K844448)Optical Micro Systems, Inc.1985-08-21
SITE-MALIS BIPOLAR COAGULATOR MODULE (K852075)Valley Forge Scientific Corp.1985-08-20
AURALITE II (K852403)Aura Lens Products1985-08-20
COOPER VISION SYSTEM VI U/S MODULE (K853070)CooperVision, Inc.1985-08-20
OCULAB TONOPEN (K852774)Oculab, Inc.1985-08-20
STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT (K851936)Staar Surgical Co.1985-08-20
PHACO-BAC STOP FILTER KIT (K852208)Staar Surgical Co.1985-08-20
EFFNER-EYE CAUTERY WITH BATTERY HANDLE (K844775)Mecron Medical Products, Inc.1985-08-12
HUMPHREY IMAGE ANALYZER MODEL 110 (K852638)Zeiss Humphrey System1985-08-12
OCULAR PRESSURE REDUCER (MCCANNEL) (K852032)Visitec Co.1985-08-12
METALLIC SUNGLASSES (K852902)Yours Enterprise Co., Ltd.1985-08-12
VISITEC 2 MICRON FLUID FILTER (K853135)Visitec Co.1985-08-09
SPECTACLE PRESCRIPTION LENSES (K853110)Ancie Laboratories1985-08-09
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 (K852271)CooperVision, Inc.1985-08-09
SUNNY SUN MAGNIFYING GLASSES (K852830)Sunny Optical Co., Ltd.1985-08-08
SUNGLASSES (K852773)Pony Industries Co., Ltd.1985-08-08
PRECISION - COSMET CAPSULE COUPEUR (K852934)Precision-Cosmet Co., Inc.1985-08-08
BEAVER MULTIPURPOSE SAPPHIRE KNIFE (K853129)Rudolph Beaver, Inc.1985-08-06
PHAKOSYSTEMS MODEL CES 4100 (K851674)Phakosystems, Inc.1985-08-05
INFUSION CANNULAM (K852758)Precision Medical Instruments, Inc.1985-08-01
MDS 83 OPHTHALMIC DYE LASER SYSTEM (K852234)Meditec, Inc.1985-08-01
ULTRATHIN/SP LENS (K843957)Optical Systems Intl., Inc.1985-07-31
ATL 225 MW TRAIL LENS SET (K852548)Ascon Medical Instruments, Ltd.1985-07-31
ANNE MARIE PERRIS SUNGLASSES AND FRAMES (K851698)Perlinea Co.1985-07-31
HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C. (K852464)Hcg, Inc.1985-07-25
MACULAR FUNCTION ANALYZER (K843227)Danek Medical, Inc.1985-07-22
COMBINED MVS SYSTEMS (K851610)Medical Instrument Development Laboratories, Inc.1985-07-22
VERSAPHAGE (K851272)Alphamedix, Inc.1985-07-05
ASCON SURGICAL INSTRUMENTS (K852057)Ascon Medical Instruments, Ltd.1985-06-27
OMS SILICONE OIL INJECTOR (K844895)Optical Micro Systems, Inc.1985-06-24
13-550,13-560 WESCOTT SCOSSORS (EYE) (K851768)Artiberia1985-06-20
MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN) (K852334)Design Med. Corp.1985-06-18
ACC CROSS CYLINDERS (K852056)Ascon Medical Instruments, Ltd.1985-06-05
SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR (K844357)Coherent Medical Group1985-06-05
ATF 101 TRAIL FRAME (K852126)Ascon Medical Instruments, Ltd.1985-06-05
PHACO PAK I (K851211)United Sonics, Inc.1985-06-05
CILCO/UNITED SONICS PHACE PF-9000 (K851209)United Sonics, Inc.1985-05-31
UNITED SONICS PHACO MODULE, DF-35 (K851210)United Sonics, Inc.1985-05-31
UNITED SONICS PACO SYSTEM MODEL 3000 (K851212)United Sonics, Inc.1985-05-31
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