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Ophthalmic

6,560 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
TECNIS MULTIFOCAL INTRAOCULAR LENS, MODEL ZMA00 (P990080/S037)Johnson & Johnson Surgical Vision, Inc.2012-05-23
LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S031)Alcon Laboratories, Inc.2012-05-23
REZOOM MULTIFOCAL INTRAOCULAR LENS, MODEL NXG1 (P080010/S008)Johnson & Johnson Surgical Vision, Inc.2012-05-23
TECNIS SOFT ACRYLIC INTRAOCULAR LENS, MODEL ZA9003 (P980040/S040)Johnson & Johnson Surgical Vision, Inc.2012-05-23
LOTRAFILCON B SOFT CONTACT LENSES (P010019/S032)Alcon Laboratories, Inc.2012-05-22
LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S030)Alcon Laboratories, Inc.2012-05-16
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P060022/S013)Bausch & Lomb, Inc.2012-05-16
AMVISC & AMVISC PLUS (P810025/S028)Bausch & Lomb, Inc.2012-05-15
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S011)CooperVision, Inc.2012-05-11
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S010)Lenstec, Inc.2012-05-11
LOTRAFILCON B SOFT CONTACT LENSES (P010019/S028)Alcon Laboratories, Inc.2012-05-11
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S065)Vistakon, Johnson & Johnson Vision Products, Inc.2012-05-09
OCUCOAT (2% HYDROXPROPYLMETHYLCELLULOSE SOLUTION) (P860047/S024)Bausch & Lomb, Inc.2012-05-04
ACRYSOF #81 MODIFIED LENS CASES (P930014/S060)Alcon Laboratories, Inc.2012-04-25
AMO CLARIFLEX INTRAOCULAR LENSES (IOL) ( MODELS CLRFLX/CLRFLXB/CLRFLXC) & TECNIS CL 3-PIECE INTRAOCULAR LENS (IOL) (P880081/S037)Johnson & Johnson Surgical Vision, Inc.2012-04-23
AMO REZOOM INTRAOCULAR LENS (IOL) MODEL NXG1 (P960028/S035)Johnson & Johnson Surgical Vision, Inc.2012-04-23
AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (IOL) (MODELS AR40E/AR40E/AR40M/AR40MN) & TECNIS 1 PIECE INTRAOCULAR LENS (P980040/S037)Johnson & Johnson Surgical Vision, Inc.2012-04-23
AMO TECNIS ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003 (P990080/S036)Johnson & Johnson Surgical Vision, Inc.2012-04-23
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS (P810031/S044)Johnson & Johnson Surgical Vision, Inc.2012-04-18
ACRYSOF INTRAOCULAR LENSES (P930014/S061)Alcon Laboratories, Inc.2012-04-11
ALLEGRETTO WAVE EXCIMER LASER SYSTEMS (P020050/S007)Alcon Laboratories, Inc.2012-04-11
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S041)Alcon Research, Ltd.2012-04-11
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEMS (P030008/S007)Alcon Laboratories, Inc.2012-04-11
CLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES (P080004/S004)Hoya Surgical Optics, Inc.2012-04-04
PERFLUORON (P950018/S015)Alcon Laboratories2012-03-30
BVI 1% OVD (!% SODIUM HYALURONATE VICSCOELASTIC SURGICAL AID FLUID (P960011/S021)Altacor , Ltd.2012-03-30
STAARVISC II & SHELLGEL SODIUM HYAURONATE (P000046/S015)Anika Therapeutics, Inc.2012-03-27
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S064)Vistakon, Johnson & Johnson Vision Products, Inc.2012-03-26
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S032)Vistakon, Division of Johnson & Johnson Vision Car2012-03-21
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P890047/S038)Alcon Research, Ltd.2012-03-12
ACRYSOF INTRAOCULAR LENSES (P930014/S059)Alcon Laboratories, Inc.2012-03-12
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM (P840064/S050)Alcon Laboratories2012-03-12
OPHTEC-STABLEYES CAPSULAR TENSION RING (P030023/S002)Ophtec BV2012-03-12
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S040)Alcon Research, Ltd.2012-03-12
RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES (P060011/S003)Rayner Intraocular Lenses , Ltd.2012-03-08
ANTERIOR CHAMBER INTRAOCULAR LENS (P010027/S005)Aaren Scientific2012-03-02
ANTERIOR CHAMBER INTRAOCULAR LENS (P010027/S004)Aaren Scientific2012-03-02
LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S029)Alcon Laboratories, Inc.2012-03-02
TECNIS MULTIFOCAL LENS MODEL ZMA00 (P080010/S007)Johnson & Johnson Surgical Vision, Inc.2012-02-29
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S010)CooperVision, Inc.2012-02-29
TECNIS 1-PEICE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00, SENSAR 1-PIECE LENS MODEL AAB00 (P980040/S038)Johnson & Johnson Surgical Vision, Inc.2012-02-29
COOPERVISION (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES (P080011/S009)CooperVision, Inc.2012-02-24
IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X (P050034/S006)Samsara Vision, Inc.2012-02-23
COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES (P080011/S008)CooperVision, Inc.2012-02-23
COOPERVISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES (P080011/S007)CooperVision, Inc.2012-02-23
ACRYSOF INTRAOCULAR LENSES (P930014/S057)Alcon Laboratories, Inc.2012-02-16
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S039)Alcon Research, Ltd.2012-02-16
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON 5 PRODUCTS (P810031/S043)Johnson & Johnson Surgical Vision, Inc.2012-02-15
BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S047)CooperVision, Inc.2012-02-10
BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S048)CooperVision, Inc.2012-02-09
BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S049)CooperVision, Inc.2012-02-09
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S031)Vistakon, Division of Johnson & Johnson Vision Car2012-02-09
FRESHLOOK UV (PHEMFILCON A) SPHERICAL SOFT CONTACT LENSES FOR EXTENDED WEAR (P830037/S053)Alcon Laboratories, Inc.2012-02-07
OCUCOAT SYRINGE PRODUCT (P860047/S025)Bausch & Lomb, Inc.2012-02-03
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON5 (P810031/S042)Johnson & Johnson Surgical Vision, Inc.2012-02-03
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) (P840064/S048)Alcon Laboratories2012-02-03
PROVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) (P890047/S036)Alcon Research, Ltd.2012-02-03
ARTISAN-VERISYSE MYOPIA PHAKIC IOL (P030028/S003)Ophtec BV2012-02-03
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM (P840064/S049)Alcon Laboratories2012-02-01
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P890047/S037)Alcon Research, Ltd.2012-02-01
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S061)Vistakon, Johnson & Johnson Vision Products, Inc.2012-02-01
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S026)Vistakon, Division of Johnson & Johnson Vision Car2012-02-01
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) (P960011/S020)Altacor , Ltd.2012-01-27
ADATO SIL-OL 5000 SILICONE OIL (P910071/S013)Bausch & Lomb2012-01-24
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S035)Alcon Research, Ltd.2012-01-20
ISPAN SULFUR HEXAFLUORIDE SF6 GAS (P900067/S007)Airgas Therapeutics, LLC2012-01-20
VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES (P840064/S047)Alcon Laboratories2012-01-20
BIOLOGICAL INDICATOR (BI) (P080004/S010)Hoya Surgical Optics, Inc.2012-01-20
STAARVISC II & SHELLGEL SODIUM HYALURONATE (P000046/S017)Anika Therapeutics, Inc.2012-01-17
AMVISC & AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES) (P810025/S029)Bausch & Lomb, Inc.2012-01-17
O2OPTIX/AIR OPTIX AQUA/AIR OPTIX FOR ASTIGMATISM/AIR OPTIX AQUA MULTIFOCAL (P010019/S027)Alcon Laboratories, Inc.2012-01-10
ISPAN PERFLUOROPROPANE C3F8 GAS (P900066/S011)Airgas Therapeutics, LLC2012-01-05
STAARVISC II, OPTIVISC/ANIKAVISC/SODIUM HYALURONATE (P000046/S020)Anika Therapeutics, Inc.2011-12-21
BIOFINITY (COMFILCON) SOFT CONTACT LENS (P080011/S005)CooperVision, Inc.2011-12-20
CLEARSOFT (METHAFILCON A) SOFT COTACT LENS (P850079/S050)CooperVision, Inc.2011-12-20
SOFTEC HD INTRAOCULAR LENS (IOL) (P090022/S007)Lenstec, Inc.2011-12-20
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S063)Vistakon, Johnson & Johnson Vision Products, Inc.2011-12-15
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S030)Vistakon, Division of Johnson & Johnson Vision Car2011-12-15
OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US (P030023/S001)Ophtec BV2011-12-14
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S028)Vistakon, Division of Johnson & Johnson Vision Car2011-12-02
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S062)Vistakon, Johnson & Johnson Vision Products, Inc.2011-12-02
FREQUENCY 55/58 UV/XCEL/EXPRESSIONS COLORS/ACCENTS/HYDRASOFT (METHAFILCON A & METHAFILCON B) SOFT (HYDROPHILIC) CONTACT (P850079/S051)CooperVision, Inc.2011-11-29
BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES (P890023/S018)The Cooper Companies2011-11-29
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S006)CooperVision, Inc.2011-11-29
WAVELIGHT EX500 LASER SYSTEM (P020050/S006)Alcon Laboratories, Inc.2011-11-23
WAVELIGHT EX500 LASER SYSTEM (P030008/S006)Alcon Laboratories, Inc.2011-11-23
C-FLEX ASPHERIC INTRAOCULAR LENS MODEL 970C (P060011/S002)Rayner Intraocular Lenses , Ltd.2011-11-22
STAR EXCIMER LASER & WAVESCAN WAVEFRONT SYSTEM (P930016/S036)Amo Manufacturing USA, LLC2011-11-17
SOFTEC HD INTRAOCULAR LENS (IOL)/SOFTEC I IOL/SOFTEC HD PS IOL (P090022/S009)Lenstec, Inc.2011-11-16
ARTISAN/VERISYSE PHAKIC IOL (P030028/S001)Ophtec BV2011-11-09
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S022)Alcon Research, Ltd.2011-11-03
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV & HEALON 5 PRODUCTS (P810031/S041)Johnson & Johnson Surgical Vision, Inc.2011-11-03
AIR OPTIX NIGHT & DAY AQUA (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S025)Alcon Laboratories, Inc.2011-11-02
ACRYSOF INTRAOCULAR LENSES (P930014/S055)Alcon Laboratories, Inc.2011-10-31
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S036)Alcon Research, Ltd.2011-10-31
LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S026)Alcon Laboratories, Inc.2011-10-28
VISTAKON (SENSOFILCON A) BRAND CONTACT LENSES (P040045/S027)Vistakon, Division of Johnson & Johnson Vision Car2011-10-26
LIMULUS AMEBOCYTE LYSATE BACTERIA TEST (P080004/S009)Hoya Surgical Optics, Inc.2011-10-26
ACRYSOF IQ TORIC INTAOCULAR LENS (P930014/S048)Alcon Laboratories, Inc.2011-10-25
BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S046)CooperVision, Inc.2011-10-21
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