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Ophthalmic

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

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RecordFirmDate
OPHTEC ENCLAVATION NEEDLE (K030471)Ophtec, USA2003-04-17
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K030092)Advanced Medical Optics, Inc.2003-04-04
SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K030548)St. shine Optical Co., Ltd.2003-04-04
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER (K030167)Clearlab Pte , Ltd.2003-04-02
GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% (K030027)Gelflex Laboratories2003-04-01
EXPRESS MINI GLAUCOMA SHUNT (K030350)Optonol, Ltd.2003-03-13
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K023455)Ciba Vision Corporation2003-02-28
SCLERAL PLUGS, 19 AND 20 GAUGE (K022186)Microvision, Inc.2003-02-26
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (K030054)Fci Ophthalmics, Inc.2003-02-26
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) (K023989)Contamac, Ltd.2003-02-26
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) (K023987)Contamac, Ltd.2003-02-26
MACROPORE SURGICAL BARRIER FILM (K023643)Macropore Biosurgery, Inc.2003-02-21
LUNEAU STERILE TONOMETER SEPARATION PRISMS (K023838)Luneau SA2003-02-20
CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) (K024045)Contamac, Ltd.2003-02-14
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT (K024164)Metro Optics, Inc.2003-02-12
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT (K024003)Gelflex2003-02-05
LID CHAIN EYELID WEIGHTS (K021750)Jedmed Instrument Co.2003-01-27
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES (K030179)Surgical Instruments Service and Savings, Inc.2003-01-24
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (K024177)Johnson & Johnson Vision Care, Inc.2003-01-22
NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (K023791)Softfocal Company, Inc.2003-01-10
MICROVISION SCLERAL BUCKLING COMPONENTS (K023481)Microvision, Inc.2003-01-08
MASTEL 1 FOLDER IMPLANTATION SYSTEM (K022723)Mastel Precision, Inc.2002-12-26
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) (K023349)Contamac, Ltd.2002-12-24
MP-1 MICRO PERIMETER (K023719)Nidek Technologies Srl2002-12-23
IRIDIS OPHTHALMIC PHOTOCOAGULATOR (K023094)Quantel Medical2002-12-17
AUTOLENS CLEANING AND DISINFECTING UNIT (K021699)Autolens, Inc.2002-12-16
KERATOME BLADE 200200 & 600600 (K020482)Micro Specialties, Inc.2002-12-16
HA ORBITAL IMPLANT (K021643)Laboratoire Villanova2002-12-13
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K023732)Ciba Vision Corporation2002-12-10
OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) (K023077)Ocu-Ease Optical Products, Inc.2002-12-10
HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) (K023530)Westcon Contact Lens Co., Inc.2002-11-26
CANON FULL AUTO TONOMETER TX-F (K023816)Canon, Inc.-Utsunomiya Optical Products Operation2002-11-26
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K022687)Ciba Vision Corporation2002-11-19
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB (K022982)Med-Logics, Inc.2002-11-15
FUNDUS AUTOIMAGER (K020888)Visual Pathways, Inc.2002-11-07
STEPHENS DISPOSABLE HOOKS (K022842)Stephens Instruments2002-11-01
STEPHENS DISPOSABLE SPECULUM (K022836)Stephens Instruments2002-11-01
STEPHENS DISPOSABLE SCISSORS (K022840)Stephens Instruments2002-11-01
GAYHEART CORNEAL EXCISION DEVICE (K022843)Stephens Instruments2002-11-01
STEPHENS DISPOSABLE FORCEPS (K022835)Stephens Instruments2002-11-01
KARATS MULTIPURPOSE SOLUTION (K021635)Ciba Vision Corporation2002-10-28
BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 (K023245)Paradigm Medical Industries, Inc.2002-10-21
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM (K023249)Alcon Laboratories, Inc.2002-10-18
BD K-4000 MICROKERATOME SYSTEM (K023092)Becton, Dickinson & CO2002-10-18
BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (K022637)Becton, Dickinson & CO2002-10-16
KOWA AUTOMATED TONOMETER KT-500 (K013805)Kowa Optimed, Inc.2002-10-11
TGDC-01 PRA (K021937)Truevision Instruments2002-10-11
CONTACT LASER & DIAGNOSTIC LENSES (K023221)Volk Optical, Inc.2002-10-11
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB (K022716)Med-Logics, Inc.2002-10-11
FP(HEXAFOCON A)RGP CONTACT LENS SPHERICAL/ASP(HEXAFOCON A)RGP CONTACT LENS ASPHERICAL (K021752)Lucid Korea Co., Ltd.2002-10-11
CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS (K022373)Cantor & Nissel , Ltd.2002-10-07
DISPOSABLE N-PE MICROKERATOME BLADES (K022205)Oasis Medical, Inc.2002-10-03
M2 SINGLE USE MICROKERTOME (K022560)Moria SA2002-09-27
MICRORUPTER V (K023045)Meridian AG2002-09-26
ICASE (K021248)Ikeeps, Inc.2002-09-24
LUNEAU 3 MIRROR LENS (K022413)Luneau SA2002-09-24
HYBRID FS & HYBRID FS TORIC (HYCOFOCON A) RGP CONTACT LENS FOR DAILY WEAR (K021977)Contamac, Ltd.2002-09-12
BENJAMIN ENVOY PHACO HANDPIECE (K022833)Benjamin Biomedical, Inc.2002-09-09
IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K021907)Igel Vision Care Pte , Ltd.2002-09-04
ALPHACOR; ALPHACOR-A (FOR AHAKIC EYES); ALPHACOR-P (FOR PHAKIC OR PSEUDOPHAKIC EYES) (K013756)Argus Biomedical Pty, Ltd.2002-08-29
BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS (K022128)Bausch & Lomb, Incorporated2002-08-22
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR (K021720)Soflex Isralens Contact Lens , Ltd.2002-08-12
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR (K021538)Lightmed Corp.2002-08-08
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K021143)Alcon Universal, Ltd.2002-08-08
F 900 (K022054)C.S.O. S.R.L.2002-08-06
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (K021357)Porex Surgical, Inc.2002-08-05
ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM (K022164)Zeta Development Laboratories2002-07-26
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 (K020527)American Optisurgical, Inc.2002-07-09
INFINITI (K021566)Alcon Laboratories, Inc.2002-07-02
HANSATOME EXCELLUS MICROKERATOME (K021640)Bausch & Lomb, Inc.2002-06-19
IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT (K020855)Igel Vision Care Pte , Ltd.2002-06-04
SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K021295)St. shine Optical Co., Ltd.2002-06-04
BIOMEDICS 52 (OCUFILCON B) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K020389)Ocular Sciences2002-06-04
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION (K020802)Bausch & Lomb, Incorporated2002-05-31
ROSE K POST GRAFT LENS (K013646)Rose K International , Ltd.2002-05-30
SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR (K020642)Soflex Contact Lens Industries , Ltd.2002-05-24
HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) (K020608)Poly Vue Technolgies, Inc.2002-05-16
SURGE-FREE ASPIRATION ADAPTER (K020734)Staar Surgical Co.2002-05-16
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS (K020927)Bausch & Lomb2002-05-16
CHROMAGEN V3.0 READING AID SOFT CONTACT LENS (K012132)Cantor & Nissel , Ltd.2002-05-09
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K020917)St. shine Optical Co., Ltd.2002-05-06
OCULIGHT SL/SLX (K020374)Iridex Corp2002-05-03
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES (K020930)Menicon Co, Ltd.2002-05-02
MID LABS AUTONOMOUS VIT ENHANCER (AVE) (K020911)Medical Instrument Development Laboratories, Inc.2002-04-29
OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS (K020690)Ocu-Ease Optical Products, Inc.2002-04-26
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR (K020392)CooperVision, Inc.2002-04-26
PVS BASIC 2; EPIC 2 (K013310)Paragon Vision Sciences2002-04-25
BLADEWORKS MICROKERATOME BLADE, MODEL 7061 (K020079)Blade Works, Inc.2002-04-19
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 (K014274)Nidek, Inc.2002-04-17
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN (K020139)Ciba Vision Corporation2002-04-09
RIGID GAS PERMEABLE CONTACT LENS (K013762)Bausch & Lomb, Incorporated2002-04-03
AQUIFY LENS COMFORT DROPS (K013204)Ciba Vision Corporation2002-04-03
DYNA INTRA-LIMBAL LENS (K020006)Lens Dynamics, Inc.2002-03-29
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS (K012852)Optonol, Ltd.2002-03-26
VISTITOME 20-10 MICROKERATOME (K014000)Biovision AG2002-03-11
STAURENGHI WIDE FIELD SCANNING LASER LENS (K014170)Ocular Instruments, Inc.2002-03-04
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (K014044)Notal Vision, Inc.2002-03-04
OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS (K020193)Cl Mcintosh2002-02-28
ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC (K013973)Vistakon2002-02-26
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K014202)Allergan, Inc.2002-02-20
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