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Ophthalmic

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

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RecordFirmDate
SENSAR 1-PIECE LENS MODEL AAB00 (P980040/S053)Johnson & Johnson Surgical Vision, Inc.2014-11-15
NIDEK EXCIMER LASER SYSTEM EC-5000 (P970053/S014)Nidek Co., Ltd.2014-11-14
TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA (P980040/S051)Johnson & Johnson Surgical Vision, Inc.2014-11-12
SILICOM(TM) 1000 RETINALTAMPONADE (P950008/S012)Alcon2014-11-03
VISCOAT,DUOVISC,DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S057)Alcon Laboratories2014-10-29
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S044)Alcon Research, Ltd.2014-10-29
TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZMB00; SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P (P980040/S050)Johnson & Johnson Surgical Vision, Inc.2014-10-23
ACRYSOF (P930014/S075)Alcon Laboratories, Inc.2014-10-21
SILSOFT (CLASTOFILCON A) CONTACT LENS (P850068/S012)Bausch & Lomb, Inc.2014-10-17
PUREVISION (BALAFILCON A) VISABILITY TINTED CONTACT LENS (P980006/S023)Bausch & Lomb, Inc.2014-10-15
RESURE SEALANT (P130004/S005)Ocular Therapeutix, Inc.2014-10-10
IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X (P050034/S013)Samsara Vision, Inc.2014-10-08
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 PRODUCTS, HEALON ULTIMATE DUAL (P810031/S051)Johnson & Johnson Surgical Vision, Inc.2014-10-08
SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS (N16895/S096)Bausch & Lomb, Inc.2014-10-02
STAR EXCIMER LASER SYSTEM (P990010/S007)Amo Manufacturing USA, LLC2014-10-02
STAR EXCIMER LASER SYSTEM (P930016/S043)Amo Manufacturing USA, LLC2014-10-02
STAR EXCIMER LASER SYSTEM (P910062/S007)Amo Manufacturing USA, LLC2014-10-02
RESURE SEALANT (P130004/S001)Ocular Therapeutix, Inc.2014-10-02
IMPLANTABLE MINIATURE TELESCOPE (P050034/S014)Samsara Vision, Inc.2014-09-12
EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (P910056/S018)Bausch & Lomb, Inc.2014-09-10
BIOFINITY (COMFILCON A) SOFT (HYDROPHILLIC) EXTENDED-WEAR CONTACT LENSES (P080011/S031)CooperVision, Inc.2014-09-09
FREQUENCY (METHAFILCON A AND B) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P850079/S067)CooperVision, Inc.2014-09-09
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S047)Vistakon, Division of Johnson & Johnson Vision Car2014-09-05
AMVISC AND AMVISC PLUS VISCOSURGICAL DEVICE (P810025/S035)Bausch & Lomb, Inc.2014-08-29
GLAUKOS ISTENT TRABECULAR MIRCO-BYPASS STENT SYSTEM (P080030/S011)Glaukos Corporation2014-08-29
ACRYSOL IQ RESTOR (P040020/S055)Alcon Research, Ltd.2014-08-20
VISTAKON SENOFILCON A BRAND CONTACT LENSES (P040045/S046)Vistakon, Division of Johnson & Johnson Vision Car2014-08-14
VISTAKON ETAFILCON A BRAND CONTACT LENSES (N18033/S074)Vistakon, Johnson & Johnson Vision Products, Inc.2014-08-14
BVI 1% OVD (P960011/S026)Altacor , Ltd.2014-08-12
EN VISTA ONE PIECE HYDROPHOBIC ACRYLIC LENS (P910056/S017)Bausch & Lomb, Inc.2014-08-01
PARAGON CRT LENS (P050031/S001)CooperVision, Inc.2014-07-28
BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS (P010062/S008)Bausch & Lomb2014-07-28
PARAGON CRT, PARAGON CRT 100, PARAGON RG-4 RIGID GAS PERMABLE CONTACT LENS (P870024/S049)CooperVision, Inc.2014-07-28
TECNIS OPTIBLUE 1-PIECE IOL (P980040/S048)Johnson & Johnson Surgical Vision, Inc.2014-07-24
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S045)Vistakon, Division of Johnson & Johnson Vision Car2014-07-23
ACRYSOF INTRAOCULAR LENSES (P930014/S073)Alcon Laboratories, Inc.2014-07-16
ACRYSOF IQ RESTOR (P040020/S054)Alcon Research, Ltd.2014-07-16
BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI (P980006/S022)Bausch & Lomb, Inc.2014-07-11
THE SOFTEC HD IOL (P090022/S023)Lenstec, Inc.2014-07-09
COOPERVISION COMFILCON A SOFT EXTENDED-WEAR CONTACT LENSES (P080011/S030)CooperVision, Inc.2014-07-08
OPHTHALMICS- ANIKAVISC, OPTIVISC AND NUVISC (P000046/S025)Anika Therapeutics, Inc.2014-07-08
TRULIGN TORIC POSTER CHAMBER INTRAOCULAR LENS (P030002/S028)Bausch & Lomb, Inc.2014-06-27
STAARVISC, OPTIVISC AND ANIKAVISC SODIUM HYALURONATE (P000046/S024)Anika Therapeutics, Inc.2014-06-24
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S020)Lenstec, Inc.2014-06-16
ISERT GEMETRIC MODEL 750 AND ISERT GEMETRIC MODEL 751 INTRAOCULAR LENS (IOL) (P080004/S015)Hoya Surgical Optics, Inc.2014-06-16
SOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S022)Lenstec, Inc.2014-06-16
AKREOS IOL (P060022/S019)Bausch & Lomb, Inc.2014-06-12
TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOL) (P980040/S043)Johnson & Johnson Surgical Vision, Inc.2014-06-11
SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES (N16895/S095)Bausch & Lomb, Inc.2014-06-06
PUREVISION (BALAFILCON A) CONTACT LENS (P980006/S018)Bausch & Lomb, Inc.2014-06-03
BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL (P080011/S029)CooperVision, Inc.2014-06-03
STAR, S41R EXCIMER LASER SYSTEM (P990010/S004)Amo Manufacturing USA, LLC2014-05-30
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P990010/S006)Amo Manufacturing USA, LLC2014-05-30
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P930016/S042)Amo Manufacturing USA, LLC2014-05-30
STAR S4 IM EXCIMER LASER SYSTEM (P910062/S004)Amo Manufacturing USA, LLC2014-05-30
WAVESCAN WAVEFRONT SYSTEM (P930016/S040)Amo Manufacturing USA, LLC2014-05-30
STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO (P910062/S006)Amo Manufacturing USA, LLC2014-05-30
BVI 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) (P960011/S025)Altacor , Ltd.2014-05-27
BALAFILCON A PRODUCT FAMILY (P980006/S015)Bausch & Lomb, Inc.2014-05-16
SILSOFT (CLASTOFILCON A) CONTACT L ENS (P850068/S010)Bausch & Lomb, Inc.2014-05-14
CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENS (IOLS) (P030002/S031)Bausch & Lomb, Inc.2014-05-13
SILSOFT(ELASTOFILCON A) CONTACT LENS (P850068/S011)Bausch & Lomb, Inc.2014-05-08
BAUSCH & LOMB SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES (N16895/S094)Bausch & Lomb, Inc.2014-05-02
BAUSCH & LOMB SOFLENS TORIC (ALPHAFILCON A) SOFT CONTACT LENSES (P960022/S009)Bausch & Lomb, Inc.2014-05-02
PROVISC (P890047/S043)Alcon Research, Ltd.2014-04-29
VISCOAT, DUOVISC,DISCOVISC (P840064/S056)Alcon Laboratories2014-04-29
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S044)Vistakon, Division of Johnson & Johnson Vision Car2014-04-29
ACRYSOF INTRAOCULAR LENS (P930014/S069)Alcon Laboratories, Inc.2014-04-28
TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM (P980040/S046)Johnson & Johnson Surgical Vision, Inc.2014-04-28
ACRYSOF RESTOR INTRAOCULAR LENS (P040020/S048)Alcon Research, Ltd.2014-04-28
EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (P910056/S016)Bausch & Lomb, Inc.2014-04-25
SOFTEC INTRAOCULAR LENSES (IOLS) (P090022/S021)Lenstec, Inc.2014-04-17
TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) (P980040/S044)Johnson & Johnson Surgical Vision, Inc.2014-04-14
WAVELIGHT EX500 EXCIMER LASER SYSTEM (P020050/S015)Alcon Laboratories, Inc.2014-04-10
NUVISC (P000046/S023)Anika Therapeutics, Inc.2014-04-10
WAVELIGHT EX500 EXCIMER LASER SYSTEM (P030008/S013)Alcon Laboratories, Inc.2014-04-10
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S043)Vistakon, Division of Johnson & Johnson Vision Car2014-04-10
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P860047/S028)Bausch & Lomb, Inc.2014-03-28
VISTAKON SENOFILCON A BRAND CONTACT LENSES (P040045/S042)Vistakon, Division of Johnson & Johnson Vision Car2014-03-28
RESURE SEALANT (P130004/S004)Ocular Therapeutix, Inc.2014-03-25
CRYSTALENS ACCOMMODATING INTRAOCULAR LENS AND TRULIGN TORIC INTRAOCULAR LENS (P030002/S030)Bausch & Lomb, Inc.2014-03-24
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (QVD) (P990023/S012)Alcon Laboratories2014-02-27
TECHNOLAS 217A EXCIMER LASER AND TEHNOLAS 217Z ZYOPTIX SYSTEMS (P990027/S019)Technolas Perfect Vision GmbH2014-02-27
COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES (P850079/S063)CooperVision, Inc.2014-02-21
WAVELIGHT EX500 LASER SYSTEM (P020050/S016)Alcon Laboratories, Inc.2014-02-20
WAVELIGHT EX500 LASER SYSTEM (P030008/S014)Alcon Laboratories, Inc.2014-02-20
CRYSTALENS ACCOMMODATING INTRAOCULAR LENS (IOL) AND TRULIGN TORIC POSTERIOR CHAMBER IOL (P030002/S029)Bausch & Lomb, Inc.2014-02-13
STAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA (P030016/S026)STAAR Surgical Company2014-02-10
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S033)Starr Surgical Co.2014-02-10
STAARVISC, OPTIVISC, AND ANIKAVISC SODIUM HYALURONATE (P000046/S021)Anika Therapeutics, Inc.2014-01-24
STAARVISC II, SHELLGEL (P000046/S022)Anika Therapeutics, Inc.2014-01-23
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S041)Vistakon, Division of Johnson & Johnson Vision Car2014-01-16
IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X (P050034/S012)Samsara Vision, Inc.2014-01-15
ACRYSOF MONOFOCAL POSTERIOR INTRAOCULAR LENSES (P930014/S071)Alcon Laboratories, Inc.2014-01-13
ACRYSOF RESTOR MULTIFOCAL POSTERIOR INTRAOCULAR LENSES (P040020/S052)Alcon Research, Ltd.2014-01-13
ACRYSOF INTRAOCULAR LENS (P930014/S070)Alcon Laboratories, Inc.2014-01-09
RESURE SEALANT (P130004)Ocular Therapeutix, Inc.2014-01-08
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S053)Alcon Research, Ltd.2013-12-30
ENVISTA IOL (P910056/S015)Bausch & Lomb, Inc.2013-12-30
ACRYSOF INTRAOCULAR LENSES (P930014/S072)Alcon Laboratories, Inc.2013-12-30
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