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Ophthalmic

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

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RecordFirmDate
PORTABLE NON-CONTACT TONOMETER, MODEL PT100 (K013259)Leica Microsystems, Inc. O.I.D.2002-02-20
MB 103 MILLENNIUM BLADES (K011833)Millennium Biomedical, Inc.2002-02-15
MB 102 MILLENNIUM BLADES (K020122)Millennium Biomedical, Inc.2002-02-15
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K013479)Allergan, Inc.2002-02-11
DC-3300 LASER DIODE PHOTOCOAGULATOR (K013760)Nidek, Inc.2002-02-11
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND (K014162)Lobob Laboratories, Inc.2002-01-15
SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS (K013649)Sauflon Pharmaceuticals, Ltd.2001-12-26
OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES (K013445)Florida Optical Engineering, Inc.2001-12-26
SOLO-CARE PLUS MULTIPURPOSE SOLUTION (K012731)Ciba Vision Corporation2001-12-26
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K013512)Ciba Vision Corporation2001-12-20
BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS (K013377)Ocular Sciences Puerto Rico, Inc.2001-12-20
SAUFLON MULTI LENS CARE SYSTEM (K010559)Sauflon Pharmaceuticals, Ltd.2001-12-20
ANISEIKONIA INSPECTOR (K013110)Optical Diagnostics, Inc.2001-12-19
ASMOTOM AUTOMATED TREPHINE SYSTEM (K013151)Bkg Opthalmics USA, Inc.2001-12-14
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI (K013337)Surgin, Inc.2001-12-13
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (K011893)Contact Color Srl2001-12-06
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (K013469)Soflex Contact Lens Industries , Ltd.2001-11-20
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) (K013220)Poly Vue Technolgies, Inc.2001-11-20
SEREINE EXTRA STRENGTH DAILY CLEANER (K011561)Wilsa, Inc.2001-11-20
CYBERCASES BY BAUSCH & LOMB (K013232)Bausch & Lomb, Inc.2001-11-20
TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR (K013467)Soflex Contact Lens Industries , Ltd.2001-11-20
DOCUMENTING LASER SLIT LAMP, DP 2010 (K012873)Bausch & Lomb, Inc.2001-11-19
VANGUARD REPROCESSED PHACOEMULSIFICATION (K012698)Vanguard Medical Concepts, Inc.2001-11-09
REPROCESSED PHACO TIPS (K012579)Sterilmed, Inc.2001-11-08
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB (K011195)Surgin Surgical Instrumentation, Inc.2001-11-06
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION (K011796)Bausch & Lomb, Inc.2001-11-01
CONFOSCAN 2 CONFOCAL MICROSCOPE (K012416)Nidek Technologies Srl2001-10-26
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER (K011392)Micra Instruments2001-10-22
D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM (K012821)Dutch Ophthalmic USA, Inc.2001-10-22
BIOMEDICS UV MULTIFOCAL (K012425)Ocular Sciences Puerto Rico, Inc.2001-10-12
ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 (K012435)Bausch & Lomb, Inc.2001-10-02
THE INTUITIVE COLORIMETER (K012298)Cerium Optical Technologies, Inc.2001-09-26
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM (K011877)Carl Zeiss Jena GmbH2001-09-26
RIGID GAS PERMEABLE CONTACT LENS SOLUTION (K011945)Polymer Technology Corp.2001-09-12
AA-1 SYSTEM (K012530)Neurovision, Inc.2001-08-31
ULTRACELL ABSORBENT STICK (K012196)Ultracell Medical Technologies, Inc.2001-08-24
DISPOSABLE VITRECTOMY LENS (K012096)Ocular Instruments, Inc.2001-08-24
GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS (K011072)Gelflex2001-08-24
LIGHTLAS 532 PHOTOCOAGULATOR (K010372)Lightmed Corp.2001-08-22
OSMED TISSUE EXPANDER (K010852)Iop, Inc.2001-08-13
THE ALBERTA LENS SM2, SULFOCON B (K010454)Progressive Optical Research , Ltd.2001-08-01
HYDRO2, HS-75 (K011914)Innovision, Inc.2001-07-27
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT (K011718)Bausch & Lomb, Inc.2001-07-25
TORIC LITE LENS (K011256)Soflex Contact Lens Industries , Ltd.2001-07-17
DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES (K011456)Sauflon Pharmaceuticals, Ltd.2001-07-17
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- (K001962)Bescon Co., Ltd.2001-07-09
EASY CONTROL MICRO INSERTER, MODEL ON385 (K011498)Ophtec USA, Inc.2001-07-09
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- (K002099)Bescon Co., Ltd.2001-07-09
PROVIEW EYE PRESSURE MONITOR (K011199)Bausch & Lomb, Inc.2001-07-02
CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) (K011740)Meddev Corp.2001-07-02
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 (K010998)Langham Ophthalmic Technologies2001-06-27
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) (K011542)Specialty Ultravision, Inc.2001-06-26
MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (K011191)Medtronic Xomed, Inc.2001-06-26
ML BLADE, MODEL ML7030 (K010872)Med-Logics, Inc.2001-06-22
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S (K011577)Ocu-Ease Optical Products, Inc.2001-06-19
MEDPOR QUAD MOTILITY IMPLANT (K010902)Porex Surgical, Inc.2001-06-19
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L (K011234)American Biocurve, Inc.2001-06-13
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T (K011316)American Contact Lens, Inc.2001-06-13
ISCREEN VISION SCREENER (K010315)Iscreen, LLC2001-06-01
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C (K011089)Specialty Ultravision, Inc.2001-05-23
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) (K004049)Optech, Inc.2001-05-23
MODIFICATION TO EDI VERIS SYSTEM (K003442)Electro-Diagnostic Imaging, Inc.2001-05-04
KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 (K011115)Heinz Kurz GmbH Medizintechnik2001-05-02
WEISS RETINAL CANNULA (K010305)Micron Surgical, Inc.2001-05-02
MED-LOGICS DISPOSABLE ALK TUBING (K010353)Med-Logics, Inc.2001-04-27
HANSATOME MICROKERATOME (K010260)Bausch & Lomb, Inc.2001-04-27
PRESCOTT'S SURGICAL SPEAR (K003842)Prescott'S, Inc.2001-04-13
VISTAKON (METHAFILCON A) CONTACT LENSES (K010507)Vistakon2001-04-12
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) (K010114)Johnson & Johnson Vision Care, Inc.2001-04-11
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL (K010256)Opti-Centre Laboratories2001-03-26
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION (K003345)Ciba Vision Corporation2001-03-26
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT (K010636)Ciba Vision Corporation2001-03-23
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) (K010223)American Contact Lens, Inc.2001-03-16
VISTAKON (HEFILCON C) CONTACT LENSES (K010218)Vistakon2001-03-16
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) (K010126)Cl-Tinters2001-03-12
D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM (K010082)Dutch Ophthalmic USA, Inc.2001-03-12
OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (K003299)Nidek Co., Ltd.2001-03-09
CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (K003594)Moria, Inc.2001-03-09
FOCUS DAILIES PROGRESSIVES (K003826)Ciba Vision Corporation2001-03-08
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) (K003861)Benz Research and Development Corp.2001-03-08
DISPOSABLE CB-PE MICROKERATOME BLADES (K003820)Oasis Medical, Inc.2001-03-08
FLUOROPERM 151-OK, PARAGON HDS 100-OK (K010109)Paragon Vision Sciences2001-02-28
MEDLOGICS ML 4000, MODEL 4000 (K002515)Med-Logics, Inc.2001-02-22
SUTUREGROOVE WEIGHT SIZING SET (K003646)Iop, Inc.2001-02-22
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT (K004000)Ocu-Ease Optical Products, Inc.2001-02-21
COMPLETE BRAND MULTI-PURPOSE SOLUTION (K003252)Allergan, Inc.2001-02-21
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR (K003996)Ocu-Ease Optical Products, Inc.2001-02-21
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT (K003789)Specialty Ultravision, Inc.2001-02-21
BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (K003933)Polymer Technology2001-02-16
BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY (K003932)Polymer Technology2001-02-16
MOJAVE CATARACT EXTRACTION SYSTEM (K003638)Allergan, Inc.2001-02-13
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR (K003833)Clearlab Pte , Ltd.2001-02-13
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE (K001585)American Biocurve, Inc.2001-02-13
SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) (K003526)Specialty Ultravision, Inc.2001-02-12
FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES (K003586)Ciba-Geigy Corp.2001-02-08
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II (K003512)A.R.C. Laser AG2001-02-08
BIO-EYE II ORBITAL IMPLANT (K003338)Integrated Orbital Implants, Inc.2001-02-07
WELCH ALLYN 11800 OPTHALMOSCOPE (K003376)Welch Allyn, Inc.2001-01-25
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT (K003042)Joe B. Goldberg, O.D.2001-01-22
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K003136)Ocular Sciences Puerto Rico, Inc.2001-01-06
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