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Ophthalmic

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

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RecordFirmDate
IVUE, MODEL 100 (K091404)Optovue, Inc.2010-04-22
ENHANCED ULTRA VIT PROBE (K093305)Alcon Research, Ltd.2010-04-02
SLIT LAMP BO 900, BQ 900, BP900 (K100202)Haag-Streit AG2010-03-19
DIGITAL RETINAL CAMERA CX-1 (K092565)Canon Components, Inc.2010-03-18
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES (K093213)Carl Zeiss Meditec, Inc.2010-03-12
SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K092852)St. shine Optical Co., Ltd.2010-03-11
PSL CLASSIC SLIT LAMP (K100500)Keeler Instruments, Inc.2010-03-09
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES (K082855)Menicon Co, Ltd.2010-03-09
AQUALASE CAPSULE WASH TIP (K093210)Alcon Manufacturing, Ltd.2010-03-04
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F (K100207)Topcon Corp.2010-02-12
ATLANTIS SLIT LAMP (K093021)Us Opthalmic, LLC2010-01-28
KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) (K093445)Keeler, Ltd.2010-01-19
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS (K091339)CooperVision, Inc.2010-01-05
FORESEE HOME (K091579)Notal Vision , Ltd.2009-12-23
LED LAMP OR OTHER (K092883)Intravista Medical Systems, Inc.2009-12-18
SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON (K090806)Safilens, S.R.L.2009-12-18
LENSX 550 LASER SYSTEM (K092647)Lensx Lasers, Inc.2009-12-11
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 (K091507)Rayner Intraocular Lenses , Ltd.2009-12-04
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 (K093639)Huvitz Co., Ltd.2009-12-03
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS (K090326)Clarity Medical Systems2009-11-25
GDXPRO (K093521)Carl Zeiss Meditec, Inc.2009-11-25
BPZ02 MULTIPURPOSE SOLUTION (K083757)Bausch & Lomb, Inc.2009-11-18
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN (K092374)Ophthalmic Imaging Systems2009-11-17
NAVILAS LASER SYSTEM (K091064)Od-Os GmbH2009-10-27
FLUID ISOLATION DEVICE (K091915)Lenstec, Inc.2009-10-27
ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (K091240)Alphamed, Inc.2009-10-23
LIPIVIEW OCULAR SURFACE INTERFEROMETER (K091935)Tearscience, Inc.2009-10-23
LENSTAR, MODEL LS900 (K082891)Haag-Streit AG2009-10-20
ALCON ULTRACHOPPER (K091777)Alcon Research, Ltd.2009-10-20
OPTOMED SMARTSCOPE, MODEL M3-1 EY1 (K092056)Optomed OY2009-10-01
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER (K091981)Lightmed Corp.2009-09-28
PASCAL STREAMLINE PHOTOCOAGULATOR (K092621)Topcon Medical Laser Systems, Inc.2009-09-25
LIGHTLAS MODEL 532 (K091534)Lightmed Corp.2009-09-18
DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER (K083288)Innova Vision, Inc.2009-09-03
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 (K092470)Topcon Corp.2009-09-02
F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY (K083428)Fiab Spa2009-09-01
LENSX 550 LASER SYSTEM (K082947)Lensx Lasers, Inc.2009-08-14
LIGHTLAS SELECTOR (K090774)Lightmed Corp.2009-08-13
GDX VCC WITH ECC SOFTWARE (K082016)Carl Zeiss Meditec, Inc.2009-08-10
KOWAGENESIS-DF (K091098)Kowa Co. , Ltd.2009-08-07
KOWA, FM-600, MODEL LSS50 (K091039)Kowa Co. , Ltd.2009-08-07
NAVIJECT SUB2-1P, MODEL: LP604430 (K092023)Medicel AG2009-07-28
ACCUPEN (K083377)Accutome Ultrasound, Inc.2009-07-27
REFRESH OPTIVE LENS COMFORT REWETTING DROPS (K083812)Allergan, Inc.2009-07-09
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM (K082871)Sis Ltd., Surgical Instrument Systems2009-07-09
KOWA VX-10 A (K091683)Kowa Co. , Ltd.2009-07-02
RETINA CAMERA TRC-NW7SF MARK II (K090115)Topcon Corp.2009-06-30
EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K082879)I-See Vision Technology, Inc.2009-06-16
EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS (K082880)I-See Vision Technology, Inc.2009-06-16
EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR (K082883)I-See Vision Technology, Inc.2009-06-16
STATIC VESSEL ANALYZER (K082196)Imedos GmbH2009-06-16
SUPRA 577.Y LASER (K091581)Quantel Medical2009-06-16
EPIPHANY INJECTION SYSTEM (K090161)Staar Surgical Co.2009-06-09
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS (K083921)Synergeyes, Inc.2009-05-20
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT (K090078)Iop, Inc.2009-05-08
CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 (K083291)Carl Zeiss Meditec, Inc.2009-05-05
CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES (K083216)Ciba Vision Corporation2009-04-14
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR (K081946)Quantel Medical2009-03-25
DIGITAL RETINAL CAMERA, CR-1 MARK II (K090466)Canon, Inc.2009-03-23
HOYA IS INJECTOR SYSTEM (K081346)Hoya Surgical Optics, Inc.2009-03-23
3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM (K083316)Topcon Medical Systems, Inc.2009-03-13
ORBITAL RECONSTRUCTIVE IMPLANT II (K083342)Evera Medical, Inc.2009-03-12
LABORPRO SYSTEM (K081984)Trig Medical, Ltd.2009-03-04
EYE SPHERES (K082850)Product and Educational Services, LLC2009-02-27
IMAG, IPOD, EZ-FIND AND ISLIDE (K090362)Voguestrap2009-02-27
INFINITI VISION SYSTEM WITH OZIL IP (K082845)Alcon Research, Ltd.2009-02-12
RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP (K083771)Clarity Medical Systems2009-01-30
HDS HI 1.54 (K082799)Paragon Vision Sciences2009-01-27
EPIVISION SL SYSTEM (K072102)Gebauer Medizintechnik GmbH2009-01-16
MODIFICATION TO KOWA NONMYD ALPHA-DIII (K083387)Kowa Co. , Ltd.2009-01-16
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS (K072971)Topcon Medical Systems, Inc.2009-01-13
BIRTHTRACK (A.K.A. CLM) (K082704)Barnev, Ltd.2009-01-09
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM (K082473)Bausch & Lomb, Inc.2009-01-05
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS (K081877)Dutch Ophthalmic Research Center International BV2009-01-05
POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K080794)Polyvue Distribution, Inc.2008-12-17
CENEFOM PVA SURGICAL SPEAR (K082460)Longtek Scientific Co., Ltd.2008-12-15
NON-CONTACT TONOMETER, MODEL FT-1000 (K073087)Tomey Corporation2008-11-18
SPECTRAL OCT/SLO (K080460)Opko Health, Inc.2008-11-14
RETCAM 3 OPHTHALMIC IMAGING SYSTEM (K081858)Clarity Medical Systems2008-11-05
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (K081382)Duckworth & Kent, Ltd.2008-10-23
KOWA NONMYD ALPHA-DIII (K082767)Kowa Co. , Ltd.2008-10-21
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM (K082944)Bausch & Lomb, Inc.2008-10-16
CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS (K080632)Clearlab SG Pte, Ltd.2008-10-15
OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES (K081178)Contamac, Ltd.2008-10-09
VITRECTOMY CUTTER AND ACCESSORIES (K081681)Advanced Medical Optics, Inc.2008-10-08
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 (K081545)Advanced Medical Optics, Inc.2008-10-02
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR (K081865)CooperVision, Inc.2008-09-29
MENICON Z RIGID GAS PERMEABLE CONTACT LENS (K081443)Menicon Co, Ltd.2008-09-23
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 (K080803)American Optisurgical, Inc.2008-09-22
SOLX 790 TITANIUM SAPPHIRE LASER (K081774)Solx, Inc.2008-09-12
PARKONE (K073508)Oculus Optikgerate GmbH2008-09-11
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS (K082393)Unilens Corp., USA2008-09-11
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 (K080776)Us Ophthalmic, LLC2008-09-09
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 (K081455)Rayner Surgical, Inc.2008-09-05
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK (K082132)Bausch & Lomb, Inc.2008-08-28
OCULAR RESPONSE ANALYZER (K081756)Reichert, Inc.2008-08-07
CARRIAZO-PENDULAR MICROKERATOME (K082043)Schwind Eye-Tech-Solutions GmbH & Co. KG2008-08-01
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES (K082031)Appasamy Associates2008-07-31
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT (K080512)Metro Optics of Austin, Inc.2008-07-23
BIRTHTRACK (K080672)Barnev, Ltd.2008-07-08
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