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Ophthalmic

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

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RecordFirmDate
BV1 1% OVD (1% SODIUM HYALURONATE VISCCOELASTIC SURGICAL AID FLUID) (P960011/S022)Altacor , Ltd.2013-03-13
ISERT GEMETRIC (P080004/S013)Hoya Surgical Optics, Inc.2013-03-13
GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L (P080030/S004)Glaukos Corporation2013-03-08
TECNIS 1-PIECE LENS (P980040/S042)Johnson & Johnson Surgical Vision, Inc.2013-03-07
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S070)Vistakon, Johnson & Johnson Vision Products, Inc.2013-03-07
GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L (P080030/S005)Glaukos Corporation2013-03-05
VISTAKON (SENOFILCON A) (P040045/S037)Vistakon, Division of Johnson & Johnson Vision Car2013-03-05
VISTAKON (ETAFILCON A) (N18033/S069)Vistakon, Johnson & Johnson Vision Products, Inc.2013-03-05
GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L (P080030/S003)Glaukos Corporation2013-03-05
VISTAKON (SENOFILCON A) (P040045/S036)Vistakon, Division of Johnson & Johnson Vision Car2013-02-27
VISTAKON (ETAFILCON A) (N18033/S068)Vistakon, Johnson & Johnson Vision Products, Inc.2013-02-27
SOFTEC HDO (P090022/S015)Lenstec, Inc.2013-02-26
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050/S009)Alcon Laboratories, Inc.2013-02-21
PHACO-FLEX AND TECHIS CL SILICONE ULTRAVIOLENT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P880081/S038)Johnson & Johnson Surgical Vision, Inc.2013-01-29
OCUCOAT HPMC VISCOELASTIC (P860047/S027)Bausch & Lomb, Inc.2013-01-29
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S012)Lenstec, Inc.2013-01-29
IMPLANTABLE MINIATURE TELESCOPE (P050034/S008)Samsara Vision, Inc.2013-01-22
TECHNOLAS 217A EXCIMER LASER SYSTEM AND TECHNOLAS 217Z ZYOPTIX SYSTEM (P990027/S017)Technolas Perfect Vision GmbH2013-01-18
ACRYSOF INTRAOCULAR LENSES (P930014/S065)Alcon Laboratories, Inc.2013-01-17
METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P850079/S064)CooperVision, Inc.2013-01-17
BIOFINITY (COMFILCON A) SOFT CONTACT LENSES (P080011/S022)CooperVision, Inc.2013-01-17
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S021)CooperVision, Inc.2013-01-17
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S035)Vistakon, Division of Johnson & Johnson Vision Car2013-01-17
ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES (P040020/S044)Alcon Research, Ltd.2013-01-17
HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON ENDOCOAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) (3 (P810031/S046)Johnson & Johnson Surgical Vision, Inc.2013-01-11
COOPERVISION COMFILCON A SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S020)CooperVision, Inc.2013-01-09
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S034)Vistakon, Division of Johnson & Johnson Vision Car2012-12-27
IMPLANTABLE MINIATURE TELESCOPE (IMT) (P050034/S007)Samsara Vision, Inc.2012-12-27
INTACS CORNEAL IMPLANTS (P980031/S011)Addition Technology2012-12-19
VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR (P820021/S035)Alcon Laboratories, Inc.2012-12-18
COOPERVISION COMFILCON A SOFT EXTENDED WEAR CONTACT LENSES (P080011/S015)CooperVision, Inc.2012-12-18
NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S012)Nidek Co., Ltd.2012-12-12
VISCOAT AND DUOVISC OPHTHALMIC VISCOSURGICAL DEVICES (OVD) (P840064/S052)Alcon Laboratories2012-12-12
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S067)Vistakon, Johnson & Johnson Vision Products, Inc.2012-12-11
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S019)CooperVision, Inc.2012-12-05
METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P850079/S062)CooperVision, Inc.2012-12-04
COPPERVISION METHAFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P850079/S060)CooperVision, Inc.2012-11-20
FREQUENCY 55, FREQUENCY 55 ASPHERIC, FREQUENCY XCEL TORIC, FREQUENCY 55 TORIC (P850079/S061)CooperVision, Inc.2012-11-20
GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S001)Glaukos Corporation2012-11-15
GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S002)Glaukos Corporation2012-11-08
EXTENDED WEAR SOFT CONTACT LENS (P830037/S054)Alcon Laboratories, Inc.2012-11-08
COOPERVISION METHAFILCON A SOFT EXTENDED WEAR CONTACT LENSES (P850079/S059)CooperVision, Inc.2012-11-08
FREQUENCY XCEL TONIC XR (P850079/S058)CooperVision, Inc.2012-11-08
BIOFINITY (CONFILCON A) SOFT CONTACT LENSES (P080011/S018)CooperVision, Inc.2012-11-01
PMMA SINGLE-PEICE POSTERIOR CHAMBER INTRAOCULAR LENSES (P840060/S038)Alcon Laboratories2012-10-31
ACYSOF MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENSES (P040020/S043)Alcon Research, Ltd.2012-10-31
PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES (P880087/S020)Alcon Laboratories2012-10-31
PMMA MULTI-PEICE POSTERIOR CHAMBER INTRAOCULAR LENSES (P810032/S062)Alcon Laboratories2012-10-31
ACRYSOF MONFOCAL AND ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENSES AND ACRYSERT DELIVERY SYSTEM (P930014/S064)Alcon Laboratories, Inc.2012-10-31
LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S034)Alcon Laboratories, Inc.2012-10-25
EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (P910056/S013)Bausch & Lomb, Inc.2012-10-19
FREQUENCY XCEL TORIC XR (P850079/S057)CooperVision, Inc.2012-10-17
ABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (P110007/S001)Johnson & Johnson Surgical Vision, Inc.2012-10-09
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS, AO60, M160 (P060022/S014)Bausch & Lomb, Inc.2012-10-04
BIOFINITY (COMFILCON A) SOFT CONTACT LENSES (P080011/S017)CooperVision, Inc.2012-09-27
LENSTEC SOFTEC HD PCIOL (P090022/S014)Lenstec, Inc.2012-09-20
COOPERVISION METHAFILCON AB EXTENDED WEAR CONTACT LENSES (P850079/S056)CooperVision, Inc.2012-09-18
GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S006)Glaukos Corporation2012-09-18
COPPERVISION METHAFILCON AB SOFT EXTENDED WEAR CONTACT LENSES (P850079/S055)CooperVision, Inc.2012-09-18
TECNIS OPTIBLUE INTRAOCULAR LENS (IOL) MODEL ZV9003 & 1-PIECE IOL MODEL ZCB00V (P980040/S035)Johnson & Johnson Surgical Vision, Inc.2012-09-12
METHAFILCON A&B SOFT EXTENDED WEAR CONTACT LENSES (P850079/S054)CooperVision, Inc.2012-09-11
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P030008/S008)Alcon Laboratories, Inc.2012-09-07
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P020050/S008)Alcon Laboratories, Inc.2012-09-07
ENVISTA INTRAOCULAR LENS (IOL) (P910056/S011)Bausch & Lomb, Inc.2012-09-04
ADATO SIL-O1 5000 SILICONE OIL (P910071/S014)Bausch & Lomb2012-08-31
EN VISTA PIECE HYDROPHOBIC ACRYLIC LENS, MODEL MX60 (P910056/S012)Bausch & Lomb, Inc.2012-08-31
SOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S013)Lenstec, Inc.2012-08-16
SODIUM HYALURONATE OPHTHALMIC VISCOELEASTIC DEVICES (OVD) HEALON, HEALON GV AND HEALON5 (P810031/S045)Johnson & Johnson Surgical Vision, Inc.2012-08-09
LOTRAFILCON SOFT CONTACT LENSES (P010019/S033)Alcon Laboratories, Inc.2012-08-09
ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES (P930014/S063)Alcon Laboratories, Inc.2012-08-09
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P860047/S026)Bausch & Lomb, Inc.2012-07-31
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S033)Vistakon, Division of Johnson & Johnson Vision Car2012-07-30
VIFILCON A SOFT CONTACT LENSES (P820021/S034)Alcon Laboratories, Inc.2012-07-30
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S066)Vistakon, Johnson & Johnson Vision Products, Inc.2012-07-30
AMVISC/AMVISC PLUS OVDS (P810025/S031)Bausch & Lomb, Inc.2012-07-27
AMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURGICAL DEVICE (P810025/S032)Bausch & Lomb, Inc.2012-07-27
DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S051)Alcon Laboratories2012-07-23
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S039)Alcon Research, Ltd.2012-07-23
C-FLEX ASPHERIC INTRAOCULAR LENS (P060011/S004)Rayner Intraocular Lenses , Ltd.2012-07-17
BIOFINILITY (COMFILCON A) SOFT (HYDROPHYLIC) EXTENDED-WEAR CONTACT LENSES (P080011/S016)CooperVision, Inc.2012-07-17
ISERT MODEL PC-60AD PACKAGING IMPROVEMENT (P080004/S012)Hoya Surgical Optics, Inc.2012-07-17
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S035)Amo Manufacturing USA, LLC2012-07-17
METHAFILCON A AND METHAFILCON B SOFT HYDROPHILIC WEAR CONTACT LENSES INSTALLATION AND VALIDATION OF A NEW 3M ATTEST 290 (P850079/S053)CooperVision, Inc.2012-07-11
COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S014)CooperVision, Inc.2012-07-09
COOPERVISION BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S013)CooperVision, Inc.2012-07-03
HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE) (P110007)Johnson & Johnson Surgical Vision, Inc.2012-07-02
COOPERVISION METHAFILCON A & B SOFT EXTENDED WEAR CONTACT LENSES (P850079/S052)CooperVision, Inc.2012-06-28
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L (P080030)Glaukos Corporation2012-06-25
ACRYSOF RESTOR POSTERIOR CHAMBER LENS (P040020/S042)Alcon Research, Ltd.2012-06-21
PMMA MULTIPEICE POSTERIOR CHAMBER LENS (P810032/S061)Alcon Laboratories2012-06-21
ACRYSOF POSTERIOR CHAMBER LENS (P930014/S062)Alcon Laboratories, Inc.2012-06-21
COPPER VISION BIOFINITY (COMFILCON A) SOFT EXTENDED WEAR CONTACT LENSES (P080011/S012)CooperVision, Inc.2012-06-19
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S012)Bausch & Lomb, Inc.2012-06-18
AMVISC & AMVISC PLUS (P810025/S027)Bausch & Lomb, Inc.2012-06-14
EXPANSION OF LATHE LINES FOR INTRAOCULAR LENS MANUFACTURING (P080004/S008)Hoya Surgical Optics, Inc.2012-06-13
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) (P090022/S011)Lenstec, Inc.2012-06-11
IMPLANTABLE COLLAMER LENS (VISIAN ICL) (P030016/S023)STAAR Surgical Company2012-06-08
ACRYSOF TORIC HIGH CYLINDER POWER IOL (P930014/S058)Alcon Laboratories, Inc.2012-06-07
EN VISTA ONE PEICE HYDROPHOBIC ACRYLIC LENS, MODEL MX60 (P910056/S010)Bausch & Lomb, Inc.2012-05-30
REZOOM MULTIFOCAL INTRAOCULAR LENS, MODEL NXG1 (P960028/S036)Johnson & Johnson Surgical Vision, Inc.2012-05-23
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