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Ophthalmic

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

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RecordFirmDate
MB 105 MILLENNIUM BLADES (K041110)Millennium Biomedical, Inc.2004-10-13
THE FUGO BLADE FOR GLAUCOMA (K041019)Medisurg , Ltd.2004-10-08
PANORAMIC 200A (K042001)Optos Plc.2004-10-07
LASEREX, MODEL LP4532 (K041598)Ellex Medical Pty, Ltd.2004-10-06
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR (K040209)Iridex Corp2004-09-20
ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS (K033599)The Lagado Corp.2004-09-16
EPITOME SYSTEM (K041206)Gebauer Medizintechnik GmbH2004-09-15
ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES (K042242)Alden Optical Labs., Inc.2004-09-15
PATHFINDER (K031788)Massie Research Laboratories, Inc.2004-09-02
CARRIAZO PENDULAR (K032910)Schwind Eye-Tech-Solutions GmbH & Co. KG2004-08-30
PHACO CHOP NEEDLES (K041998)Bausch & Lomb, Inc.2004-08-16
CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR (K041700)Cantor & Nissel , Ltd.2004-07-30
SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR (K033655)Soflex Contact Lens Industries , Ltd.2004-07-30
LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS (K041138)CooperVision, Inc.2004-07-23
NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) (K040913)Bausch & Lomb2004-07-23
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (K040851)Porex Surgical, Inc.2004-07-16
C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS (K041608)Unilens Corp., USA2004-07-07
VARILUX VISIONPRINT SYSTEM (VPS) (K033949)Essilor Intl.2004-07-02
DIGITAL FUNDUS CAMERA, MODEL CF-60DSI (K041546)Canon, Inc.2004-06-23
M3 MICROKERATOME (K032836)Moria SA2004-06-18
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE (K040837)Medicel AG2004-06-17
S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K040900)Optical Connection, Inc.2004-06-15
RE-USEABLE MICROSTAAR INJECTOR, MSI-S (K032412)Staar Surgical Co.2004-06-10
EYE SPHERE IMPLANTS (K040689)Oculo Plastik, Inc.2004-06-10
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS (K040914)Exero Products, Inc.2004-05-27
M2 COMPATIBLE MICROKERATOME BLADE (K033457)Micro Specialties, Inc.2004-05-25
RTA MODEL D RETINAL THICKNESS ANALYZER (K041290)Talia Technology , Ltd.2004-05-24
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE (K033123)Carl Zeiss Meditec, Inc.2004-04-20
ONEUSE- PLUS MICROKERATOME (K040297)Moria SA2004-03-31
PRIZM KERATOME BLADE, MODEL MK8512M2 (K033236)Surgin Surgical Instrumentation, Inc.2004-03-26
ZYOPTIX XP MICROKERATOME (K040204)Bausch & Lomb, Inc.2004-03-22
OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES (K033594)Contamac, Ltd.2004-03-19
KERATO ANALYZER (EKA) (K040373)Konan Medical, Inc.2004-03-19
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS (K033919)Ciba Vision Corporation2004-03-12
PANORET, MODEL PNM 60 (K040325)Medibell Medical Vision Technologies , Ltd.2004-03-08
I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 (K033136)Innova Vision, Inc.2004-03-05
HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES (K031774)Westcon Contact Lens Co., Inc.2004-02-20
DORC VITRECTOMY LENSES, MODEL 1284 SERIES (K033950)Dutch Ophthalmic Research Center (D.O.R.C.)2004-02-20
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK (K033941)Bausch & Lomb, Inc.2004-02-10
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (K033969)Vistakon2004-02-04
AQUIFY MULTI-PURPOSE SOLUTION (K033608)Ciba Vision Corporation2004-02-02
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE (K033656)Sauflon Pharmaceuticals, Ltd.2004-02-02
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (K033182)Surgin Surgical Instrumentation, Inc.2004-01-30
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER (K032799)Reichert, Inc.2004-01-20
MED-LOGICS, MODEL ML7090 (K033293)Med-Logics, Inc.2004-01-13
SURGICAL MEDICAL DEVICE CAUTERY (K023506)Modern Medical Equipment Mfg., Ltd.2004-01-13
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (K031831)Topcon Medical Systems, Inc.2003-12-19
VENTURI PHACO PACK (K033653)Bausch & Lomb, Inc.2003-12-17
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES (K033701)Ciba Vision Corporation2003-12-15
AMNIOLENS (K032104)Bio-Tissue, Inc.2003-12-12
NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY (K032309)Novelens, Inc.2003-12-04
VISION-TECH YZ SLIT LAMP, MODEL 66 (K033190)Suzhou 66 Vision-Tech Co., Ltd.2003-12-04
NON-CONTACT TONOMETER, MODEL NT-4000 (K031733)Nidek, Inc.2003-12-04
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (K032087)Keeler Instruments, Inc.2003-11-26
BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 (K031646)Bausch & Lomb, Inc.2003-11-14
PASCAL DYNAMIC CONTOUR TONOMETER (K032967)Smt Swiss Microtechnology AG2003-11-14
PROCLEAR COMPATIBLES MULTIFOCAL (K032873)CooperVision, Inc.2003-11-07
THERATEARS CONTACT LENS COMFORT DROPS (K032481)Advanced Vision Research, Inc.2003-11-04
COLIBRI DISPOSABLE VITRECTOMY CUTTER (K033390)Microworld Medical Instruments, Inc.2003-11-04
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME (K032978)Ciba Vision Corporation2003-10-20
VISTAKON (GALYFILCON A) SOFT CONTACT LENS (K032340)Johnson & Johnson Vision Care, Inc.2003-10-16
CLUED UP MULTIPURPOSE SOLUTION- NO RUB (K030910)Clued UP Limited2003-10-10
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM (K024072)Duckworth & Kent, Ltd.2003-10-06
BLINK CL LUBRICANT EYE DROPS (K032030)Advanced Medical Optics, Inc.2003-09-25
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER (K030393)Haag-Streit Holding AG2003-09-25
EYESOPEN TONOMETER (K032769)Eye-Deas, LLC2003-09-23
PENTACAM SCHEIMPFLUG CAMERA (K030719)Oculus Optikgerate GmbH2003-09-16
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K030522)Ciba Vision Corporation2003-09-12
QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE (K032256)No 7 Contact Lens Laboratory , Ltd.2003-08-29
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS (K031665)Iridex Corp2003-08-27
DISPOSABLE N-PE MICKROKERATOME BLADES (K032297)Oasis Medical, Inc.2003-08-26
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (K023400)Fci Ophthalmics, Inc.2003-08-22
CENTURION SES EPIKERATOME (K031735)Ciba Vision Corporation2003-08-21
PERFECT CAPSULE (K030957)Milvella Pty. , Ltd.2003-08-20
MODIFICATION TO KARATS MULTI-PURPOSE SOLUTION (K031957)Ciba Vision Corporation2003-08-14
SOLID STATE LAMP [LED] HEADLIGHT (K031549)Welch Allyn, Inc.2003-08-11
LED HEADLIGHT (K031548)Welch Allyn, Inc.2003-08-11
SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR (K031532)Metro Optics of Austin, Inc.2003-08-01
SAUFLON MULTIPURPOSE SOLUTION - NO RUB (K030278)Sauflon Pharmaceuticals, Ltd.2003-07-30
HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS (K031477)Ocular Sciences, Inc.2003-07-18
INJECTOR (K023737)Anton Meyer & Co. , Ltd.2003-07-14
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION (K031193)Alcon, Inc.2003-07-03
SOLO-CARE PLUS MULTIPURPOSE SOLUTION (K031522)Ciba Vision Corporation2003-06-27
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 (K031023)Peregrine Surgical , Ltd.2003-06-27
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K031521)Ciba Vision Corporation2003-06-27
DISPOSABLE M2-PE MICROKERATOME BLADES (K030401)Oasis Medical, Inc.2003-06-19
VMATE MODEL VMM1000 (K030948)Howard Instruments, Inc.2003-06-17
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK (K030891)Surgistar, Inc.2003-06-17
CONTACT LENS STORAGE CASE (K030987)Pelican Products2003-06-12
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI (K031629)Canon USA, Inc.2003-06-06
ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP (K030842)Soflex Contact Lens Industries , Ltd.2003-06-06
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC (K030593)X-Cel Contacts, A Walman Co.2003-05-30
DIGNITY OPHTHALMIC SURGICAL SYSTEM (K031404)Phacor Inc., A Santen Company2003-05-22
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER (K030748)Clearlab Pte , Ltd.2003-05-14
RTA MODEL D RETINAL THICKNESS ANALYZER (K031312)Talia Technology , Ltd.2003-05-06
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION (K024289)Bausch & Lomb, Incorporated2003-05-02
STRATUSOCT WITH RNFL NORMATIVE DATABASE (K030433)Carl Zeiss Meditec, Inc.2003-05-01
APPLANATION TONOMETER (K023676)Optilasa, S.L.2003-04-24
NOVAVISION, MODEL 2.0 (K023623)Novavision, Inc.2003-04-22
VELOCITY ADVANTAGE (K023939)Visioncare Devices, Inc.2003-04-17
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