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Ophthalmic

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

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RecordFirmDate
MONARCH II IOL DELIVERY SYSTEM (K003768)Alcon Research, Ltd.2001-01-05
LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML (K003031)Alpha Vista, Inc.2001-01-05
PHACOGARD (K002932)Syntec, Inc.2001-01-04
PHACOFRAGMENTATION SYSTEM MEGATRON (K002031)Asclepion-Meditec AG2000-12-27
PEDIATRIC INGESTASCAN (K003305)Adams Electronics, Inc.2000-12-22
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 (K003036)Retinalabs.Com2000-12-22
MEGAVISION CPX, MEGAVISION FA, MODEL I AND II (K002920)Escalon Medical Corp.2000-12-18
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT (K003161)Les Laboratoires Blanchard2000-12-15
RYTHMIC AND RYTHMIC UV (K003170)Essilor Intl.2000-12-15
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K003071)Ciba Vision Corporation2000-12-13
MODEL 30 CLASSIC PNEUMATONOMETER (K002395)Xomed, Inc.2000-12-11
MILLENNIUM BLADES, MODEL MB101 (K003143)Millennium Biomedical, Inc.2000-12-11
PAFLUFOCON C AND E DAILY CONTACT LENS (K002845)Paragon Vision Sciences2000-12-08
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 (K002986)A.R.C. Laser AG2000-11-29
O-PERM 30 (K002703)Optical Polymer Research, Inc.2000-11-21
COMPLETE BRAND LUBRICATING AND REWETTING DROPS (K003109)Allergan, Inc.2000-11-21
SPECIALTY TINT SOFT CONTACT LENS (K003079)Specialty Tint2000-11-21
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (K002966)Ocu-Ease Optical Products, Inc.2000-11-08
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE (K002812)Michael Reynard, M.D.2000-11-08
RETINADX (K003236)Regulatory Associates, Inc.2000-11-02
RIGID GAS PERMEABLE CONTACT LENS (K002025)Polymer Technology2000-10-31
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1 (K002556)Pharmacia & Upjohn Co.2000-10-31
THERMAL CAUTERY UNIT, MODEL 150 (K002341)Geiger Medical Technologies, Inc.2000-10-23
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K002589)Alcon Universal, Ltd.2000-10-23
VISIJET HYDROKERATOME, MODEL 50 (K991124)Visijet, Inc.2000-10-20
STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR (K002547)Starion Instruments2000-10-20
CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES (K994320)Cantor & Silver , Ltd.2000-10-20
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES (K002849)Surgical Specialties Corp2000-10-18
SMARTLENS (K002510)Odc Ophthalmic Development Co. AG2000-10-18
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION (K002823)Bausch & Lomb, Inc.2000-10-17
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS (K002408)Unilens Corp., USA2000-10-17
CARRIAZO BARRAQUER II MICROKERATOME (K002191)Moria, Inc.2000-10-12
MENICON PROGENT REMOVER (K002140)Menicon Co, Ltd.2000-10-10
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (K001125)Geuder GmbH2000-10-04
DISPOSABLE H-PE MICROKERATOME BLADES (K001464)Oasis2000-10-02
LIPIDURE REWETTING DROPS (K000975)Nof Corp.2000-09-25
DISPOSABLE MICROKERATOME BLADES-PE (K001176)Oasis Medical, Inc.2000-09-21
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ (K994340)Hai Laboratories, Inc.2000-09-20
METHAFILCON A (K002625)CooperVision, Inc.2000-09-13
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS (K002647)Marietta Contact Lens Service2000-09-13
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT (K002044)Magna Fortis Corporation2000-09-12
REFRACTIVE SURGERY BLADES (K001806)Millennium Biomedical, Inc.2000-09-12
PURILENS SALINE SOLUTION (K002319)Purilens, Inc.2000-08-30
RIGID GAS PERMEABLE CONTACT LENS (K001960)Polymer Technology2000-08-28
ML EYE SPEAR, MODEL ML 27 ES (K002279)Med-Logics, Inc.2000-08-18
KONTUR 55 SOFT LENS (K001908)Kontur Kontact Lens Co., Inc.2000-08-18
THE FUGO BLADE (K001498)Medisurg , Ltd.2000-08-10
RENU MULTIPLUS MULTI-PURPOSE SOLUTION (K001539)Bausch & Lomb, Inc.2000-07-31
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION (K001964)Lobob Laboratories, Inc.2000-07-18
RETCAM II (K001275)Massie Research Laboratories, Inc.2000-07-13
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION (K001214)Alcon Universal, Ltd.2000-07-10
PANORET, MODEL 1000A (K001111)Cmt Medical Technologies, Ltd.2000-07-07
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA (K001772)Taracan Pty. , Ltd.2000-07-06
OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 (K001235)Alcon Universal, Ltd.2000-07-03
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT (K001227)Opti-Centre Laboratories2000-06-29
MONARCH II IOL DELIVERY SYSTEM (K001157)Alcon Research, Ltd.2000-06-27
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 (K992606)Canon USA, Inc.2000-06-21
AC POWERED THERMAL CAUTERY UNIT (K000893)Starion Instruments2000-06-14
NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON (K001326)Ocular Concepts, LLC2000-06-13
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN (K001620)Metro Optics of Austin, Inc.2000-06-13
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT (K001584)Medvice Consulting, Inc.2000-06-13
C.S.O. TONOMETER (K992835)Cso2000-06-06
BONASSE CONTACT LENS CASE (K991206)Bonasse Ent. Co., Ltd.2000-06-06
OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES (K000998)Optisonic, Inc.2000-06-05
COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION (K000164)Allergan, Inc.2000-06-02
OPTIMUM WETTING AND REWETTING DROP (K001428)Lobob Laboratories, Inc.2000-05-26
RIGID GAS PERMEABLE CONTACT LENS (K000795)Polymer Technology2000-05-26
SPORTSIGHT GP (K993586)Paragon Vision Sciences2000-05-22
MENICON SF-P (K000233)Menicon Co, Ltd.2000-05-19
METHAFILCON A (K001090)CooperVision, Inc.2000-05-19
POLYMACON (K001089)CooperVision, Inc.2000-05-19
CUSTOMCORNEA MEASUREMENT DEVICE (CCMD) (K000637)Alcon Laboratories, Inc.2000-05-19
MENICON Z (K000133)Menicon U.S.A., Inc.2000-05-19
SOLO-CARE BRAND HARD SOLUTION (K000607)Ciba Vision Corporation2000-05-15
HYDRO2, HS-75 (K000485)Innovision, Inc.2000-05-12
HEADLAMP HL2000. (K994362)Angiolaz, Inc.2000-05-11
VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES (K000457)Retinalabs.Com2000-05-09
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS (K001144)Lasersight Technologies, Inc.2000-05-05
EYECAP IMAGING SYSTEM (K000368)Clement Clarke Intl., Ltd.2000-05-04
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (K000327)Visx, Incorporated2000-05-02
OPTI-FREE EXPRESS LENS DROPS (K000385)Alcon Universal, Ltd.2000-04-28
KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 (K001123)Heinz Kurz GmbH Medizintechnik2000-04-21
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER (K000247)Bausch & Lomb, Inc.2000-04-20
BIOCERAMIC ORBITAL IMPLANT (K992294)Fci Ophthalmics, Inc.2000-04-19
FLUROPERM 60-OK, PARAGON HDS-OK (K000224)Paragon Vision Sciences2000-04-17
SUTUREGROOVE (K994289)Iop, Inc.2000-04-17
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS (K993489)Crystal Reflections, Int., Inc.2000-04-14
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 (K000127)Heinz Kurz GmbH Medizintechnik2000-04-12
RGP MULTI-PURPOSE SOLUTION ID 100136 (K000148)Alcon Laboratories2000-04-11
PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE (K000151)Integrated Orbital Implants, Inc.2000-04-10
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER (K000731)Talia Technology , Ltd.2000-03-31
REICHERT CT200 CONTACT TONOMETER (K000288)Reichert Ophthalmic Instruments, Div. Leica, Inc.2000-03-23
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT (K000376)Specialty Ultravision, Inc.2000-03-21
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) (K000529)The Lifestyle Co., Inc.2000-03-21
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER (K991840)Bernard B. Fresco2000-03-20
IOLMASTER (K993357)Carl Zeiss, Inc.2000-03-20
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS (K994335)Wesley Jessen Corp.2000-03-20
BLADEWORKS MICROKERATOME BLADE (K993225)Blade Works, Inc.2000-03-20
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C (K000439)Wesley Jessen Corp.2000-03-20
MSP M/K BLADE (K993122)Medical Sterile Products, Inc.2000-03-16
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