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Ophthalmic

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

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RecordFirmDate
OPACITRAC (K915356)Oculon Corp.1992-02-21
STORZ MICRO CUTTER 25 GAUGE PACK (K913504)Storz1992-02-21
OPTICAL FRAMES & SUNGLASSES (K914310)Societe Nouvelle Idc1992-02-19
REGENCY, COMPARE, SUN OPTICS SUNGLASSES (K913419)Cliff Weil, Inc.1992-02-12
PHACO 3000 LINEAR (K915456)Innovative Medical Systems, Inc.1992-02-12
SUNGLASSES (NON-PRESCRIPTION) (K920165)Blair Corporation1992-02-11
SUNSHADES, ACRYLIC LENSES, SILVER COATED #HX-602 (K913686)Tel-Time Products1992-02-11
LASER FLARE METER (K913852)Kowa Optimed, Inc.1992-02-07
IRRIGATOR/ASPIRATOR PROBE (K915074)Biomedical Dynamics, Inc.1992-02-05
WETTING SOLUTION FOR HARD CONTACT LENSES (K914483)Optopics Laboratories Corp.1992-02-05
GOLDLENS(TM) (K913239)Doran Instruments, Inc.1992-01-31
INSTRUMENT WIPE AND CORNEAL SHIELD (K912576)Katena Products, Inc.1992-01-31
DWYER EYE SYSTEMS ASPIRATION UNIT (K913261)Spectracare, Inc.1992-01-30
CHIROFLEX II LENS MICROSERT(TM) (K914311)Chiron Ophthalmics1992-01-27
GRIESHABER AIR/FLUID TUBING SET (K914587)Grieshaber & Co.1992-01-23
FRIEDMANN ANALYSER 3 (K914896)Clement Clarke, Inc.1992-01-23
CANDELA RETINAL CAMERA (K913314)Candela Laser Corp.1992-01-23
DOHLMAN DOANE KERATOPROTHESIS (K915062)Mackeen Consultants, Ltd.1992-01-21
SUN SIGHT SUNGLASSES/SUN SIGHT READING GLASSES (K914766)Sun Sight Glasses Co., Ltd.1992-01-17
OPTI-LENS(TM) CONTACT LENS CASE (K915082)Ryder Intl. Corp.1992-01-13
MOSSIMO OPTIC EYEWEAR (K912509)Mossimo, Inc.1992-01-06
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE (K914484)Hgm Medical Laser Systems, Inc.1992-01-06
PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION) (K914407)Promedex, Inc.1991-12-31
SPECTACLE FRAMES (K914413)Mikado Ca.1991-12-31
PYRAMID SUNGLASSES/READING GLASSES (K914425)Pyramid1991-12-31
ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (K912740)Visionary Systems, Inc.1991-12-30
FRAMES (SPECTACLES) VARIOUS TYPES (K914614)Match Optical Co.1991-12-30
PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE (K915118)Ipax, Inc.1991-12-27
PHACO TIP (K914229)Tri-Star Ophthalmic1991-12-27
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE (K912384)Nidek, Inc.1991-12-24
LULMITEX NEONATAL TRANSILLUMINATOR (K912747)Lumitex, Inc.1991-12-24
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) (K912581)Carl Zeiss, Inc.1991-12-23
SOFTRANS INJECTOR (K913626)Staar Surgical Co.1991-12-18
PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE (K912902)Site Microsurgical Systems, Inc.1991-12-17
FRAMES (SPECTACLES) (K914239)Jane Fui Optical Co., Ltd.1991-12-16
TANDEM SCANNING MICROSCOPE (K912514)Tandem Scanning Corp.1991-12-16
PEDIATRIC VITRECTOMY LENS SET (K914051)Ocular Instruments, Inc.1991-12-09
POLLY'S CUTTER J-225 (K914038)O.R. Specialties, Inc.1991-12-09
DROLITE(TM) LIGHT SOURCE (K913273)Vision Medical, Inc.1991-12-04
OPHTHALMIC STAND (K913961)Luneau Ophtalmologie SA1991-12-04
DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM (K913929)Ophthalmic Imaging Systems1991-11-27
SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS (K914529)Oasis Medical, Inc.1991-11-13
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET (K914117)Ocular Instruments, Inc.1991-11-13
TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM (K911734)Northland Cataract & Eye Care Clinic1991-11-07
AUTOMATIC CORNEAL SHAPER (K913697)Hansa Research & Development, Inc.1991-11-05
MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM (K913837)Vision Medical, Inc.1991-11-05
PEEPERS TANNING GOGGLES (K914095)California Suncare, Inc.1991-10-30
KPE 230 AM (K914172)Ipax, Inc.1991-10-25
SCOPTOPIC SENSITIVITY TEST-1[SST-1] (K914163)Lkc Technologies, Inc.1991-10-25
KPE 220 TS, NONSTERILE (K914221)Ipax, Inc.1991-10-25
PROFESSIONAL INDIRECT OPHTHALMOSCOPE (K912397)Clement Clarke, Inc.1991-10-23
ANOMALOSCOPE QUADRANT TEST-6 (K913962)Lkc Technologies, Inc.1991-10-23
LOOK VISCODISSECTOR (K913530)Look, Inc.1991-10-21
DR. DEAN EDELL SOLARBLOC SUNGLASSES (K913640)Cable Car Sunglasses1991-10-21
DUCAL SIDE SHIELD SUNGLASS (K913745)Ducal Trading Corp.1991-10-15
COLLAGEN SHIELD FOR ACUTE CARE (K913148)Vitaphore Corp.1991-10-15
NIDEK MODEL NT-1000 (K913189)Nidek, Inc.1991-10-15
TURBOTRON 20/20 (K902920)Prestige Manufacturing Snd Bhd1991-10-10
GLAUCOMA-SCOPE (K913118)Ophthalmic Imaging Systems1991-10-09
CCI VIDEOKERATOSCOPE/COMPARATOR (K913022)Cci1991-10-09
UNIDIRECTIONAL OCCLUDER (K913230)Welch Allyn, Inc.1991-10-02
EYE BUBBLE (K912367)Aaron Medical Industries1991-10-02
THE PAN.OPTX SPORTGLASS (K913388)Panoptx, Inc.1991-10-02
HEIDELBERG RETINA TOMOGRAPH (K912891)Heidelberg Engineering1991-09-27
DESERT SHIELD SUNGLASSES (K912863)Command Marketing Corp.1991-09-25
ARTIFICIAL SCLERAL SHELL (K904961)Midwest Eye Laboratories, Inc.1991-08-30
EYE ARTIFICIAL CUSTOM (K904962)Midwest Eye Laboratories, Inc.1991-08-30
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE (K912739)Site Microsurgical Systems, Inc.1991-08-28
FRAMES (EYE GLASSES) (K913046)Jiuh Chyi Ent. Co., Ltd.1991-08-28
VENETO COLLECTION (K912034)Atlantic Optical Co., Inc.1991-08-22
STAR*SHADES(TM) SUNGLASSES (K912608)Nalpac , Ltd.1991-08-21
LANDERS WIDE FIELD TEMPORARY KERATOPROSTHESIS (K910828)Ocular Instruments, Inc.1991-08-21
PMT METAL LOCATOR, MODEL 3630-1 (K911886)Pmt Corp.1991-08-12
TBD KERATOSCOPE (K912130)Alcon Laboratories1991-08-09
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING (K912269)Ocular Instruments, Inc.1991-08-07
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING (K912253)Ocular Instruments, Inc.1991-08-07
LANDERS NOTCHED VITRECTOMY LENS RING (K912268)Ocular Instruments, Inc.1991-08-07
PLASTIC OVERLAYS (K911374)National Reading Service1991-07-26
MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM (K911998)Allergan Medical Optics1991-07-26
TBD, LENS MEASURING DEVICE (K912134)Alcon Laboratories1991-07-25
LANDERS THREE STRUT VITRECTOMY LENS RING (K912151)Ocular Instruments, Inc.1991-07-25
EASY EYES TM CONTACT LENS CLEANING MACHINE (K904824)Eaton Medical Corp.1991-07-05
MAINSTER HIGH MAGNIFICATION LASER LENS (K912366)Ocular Instruments, Inc.1991-06-25
GEMINI OPHTHALMIC SURGERY SYSTEM (K911808)Alcon Laboratories1991-06-25
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION (K911721)Keeler Instruments, Inc.1991-06-25
SLIMCATH (TM) (K903001)Gynopharma, Inc.1991-06-25
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS (K911110)G.W.B. Intl., Ltd.1991-06-18
PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (K912112)Tomey Corporation USA1991-06-17
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF (K911439)Canon USA, Inc.1991-06-17
COLLAGEN SHIELD, VARIOUS MODELS (K905825)Chiron Ophthalmics1991-06-10
ORIGINALS (K911277)Face 2 Face Corp.1991-06-06
URAM OPHTHALMIC LASER ENDOSCOPE (K910532)Martin S. Knopf Assoc., Inc.1991-05-28
ND:YAG LASER SYSTEMS (VARIOUS MODELS) (K910805)Heraeus Lasersonics, Inc.1991-05-24
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE (K910980)Site Microsurgical Systems, Inc.1991-05-22
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY (K911062)Storz Instrument Co.1991-05-22
SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. (K911766)Gall'S, Inc.1991-05-22
PATHFINDER (K910601)Nurion Industries1991-05-14
SPECTACLE FRAME (K911332)Australian Optical Co., Inc.1991-05-06
OPTHLAMIC FRAMES (K910951)United Optical, Spa1991-05-06
SUNGLASSES (K910415)K.M Optical Co.1991-05-01
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