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Ophthalmic

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

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RecordFirmDate
SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES (P960039/S003)Unilens Corporation, USA2008-03-03
SOF-FORM 55 EW AND LL-55 SOFT HYDROPHILIC SPHERICAL CONTACT LENSES (P890040/S006)Unilens Corp., USA2008-03-03
BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY (P960011/S013)Altacor , Ltd.2008-02-29
MODEL SA40N ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P960028/S029)Johnson & Johnson Surgical Vision, Inc.2008-02-27
ARRAY MULTIFOCAL ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S028)Johnson & Johnson Surgical Vision, Inc.2008-02-27
ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL) (P880081/S036)Johnson & Johnson Surgical Vision, Inc.2008-02-27
BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT (P010062/S006)Bausch & Lomb2008-02-21
BOSTON EQUALENS (ITAFLUOROFOCON A) RIGID GAS PERMEABLE CONTACT LENS, EQUALENS 2 (OPRIFOCON A) RIGID GAS PERMEARABLE LENS (P860022/S057)Bausch & Lomb2008-02-21
MEL 80 EXCIMER LASER SYSTEM (P060004/S002)Carl Zeiss Meditec, Inc.2008-02-14
LOTRAFILCON A & B SOFT CONTACT LENSES (P010019/S008)Alcon Laboratories, Inc.2008-02-12
LOTRAFILCON SOFT CONTACT LENSES (P010019/S007)Alcon Laboratories, Inc.2008-02-08
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S007)Alcon Research, Ltd.2008-02-06
TECNIS 1-PIECE IOL MODEL ZCB00 (P980040/S022)Johnson & Johnson Surgical Vision, Inc.2008-02-01
BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM (P990027/S009)Technolas Perfect Vision GmbH2008-02-01
COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990013/S014)Starr Surgical Co.2008-01-25
SENSAR ACRYLIC MONOFOCAL IOLS (P980040/S020)Johnson & Johnson Surgical Vision, Inc.2008-01-23
REZOOM MULTIFOCAL IOLS (P960028/S026)Johnson & Johnson Surgical Vision, Inc.2008-01-23
TECNIS ACRYLIC MONOFOCAL IOLS (P990080/S029)Johnson & Johnson Surgical Vision, Inc.2008-01-23
VISTAKON SENOFILCON A CONTACT LENS FOR EXTENDED WEAR (P040045/S003)Vistakon, Division of Johnson & Johnson Vision Car2008-01-18
STAAR SURGICAL SILICONE UV - ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S024)Staar Surgical Co.2008-01-16
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) WAVESCAN WAVEFRONT SYSTEM (P930016/S030)Amo Manufacturing USA, LLC2008-01-16
VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S034)Alcon Laboratories2008-01-04
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S021)Alcon Research, Ltd.2008-01-04
VISCOAT,DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S033)Alcon Laboratories2007-12-14
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S020)Alcon Research, Ltd.2007-12-14
ADATO SIL-OL 5000 SILICONE OIL (P910071/S010)Bausch & Lomb2007-12-12
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL) (P030002/S013)Bausch & Lomb, Inc.2007-12-12
SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S023)Staar Surgical Co.2007-12-04
ACRYSOF INTRAOCULAR LENSES (IOL) (P930014/S022)Alcon Laboratories, Inc.2007-11-30
ACRYSOF INTRAOCULAR LENSES (IOL) (P040020/S006)Alcon Research, Ltd.2007-11-30
UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES (P880081/S035)Johnson & Johnson Surgical Vision, Inc.2007-11-19
CEEON & TECNIS UV-ABORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990080/S028)Johnson & Johnson Surgical Vision, Inc.2007-11-19
SENSAR SOFT ACRYLIC POSTERIOR CHAMBER INTRACULAR LENSES (P980040/S019)Johnson & Johnson Surgical Vision, Inc.2007-11-19
MULTIFOCAL SILICONE & MULTIFOCAL ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENSES (P960028/S025)Johnson & Johnson Surgical Vision, Inc.2007-11-19
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S027)Amo Manufacturing USA, LLC2007-11-09
SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00) (P980040/S015)Johnson & Johnson Surgical Vision, Inc.2007-10-30
SILICONE IOLS (P880081/S034)Johnson & Johnson Surgical Vision, Inc.2007-10-24
ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL (P040020/S005)Alcon Research, Ltd.2007-10-24
TECNIS ACRYLIC IOLS (P990080/S027)Johnson & Johnson Surgical Vision, Inc.2007-10-24
SENSAR ACRYLIC IOLS (P980040/S018)Johnson & Johnson Surgical Vision, Inc.2007-10-24
ARRAY MULTIFOCAL IOLS & REZOOM MULTIFOCAL IOLS (P960028/S024)Johnson & Johnson Surgical Vision, Inc.2007-10-24
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (P030002/S012)Bausch & Lomb, Inc.2007-09-26
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES (P980006/S011)Bausch & Lomb, Inc.2007-09-19
BIOLON 1% SODIUM HYALURONATE (P960011/S011)Altacor , Ltd.2007-09-13
ADATO SIL-OL 5000 SILICONE OIL (P910071/S009)Bausch & Lomb2007-09-12
ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC INTRAOCULAR LENS (IOL) (P040020/S004)Alcon Research, Ltd.2007-09-06
ACRYSOF SINGLE-PIECE INTRAOCULAR LENS (IOL) (P930014/S020)Alcon Laboratories, Inc.2007-09-06
VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES (P840064/S032)Alcon Laboratories2007-08-30
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S019)Alcon Research, Ltd.2007-08-30
SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) (P960028/S023)Johnson & Johnson Surgical Vision, Inc.2007-08-30
HEALON,HEALON GV, & HEALON5 SODIUM HYALURONATE VISCOELASTIC (P810031/S033)Johnson & Johnson Surgical Vision, Inc.2007-08-30
SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) (P990080/S026)Johnson & Johnson Surgical Vision, Inc.2007-08-30
SOFT ACRYLIC INTRAOCULAR LENSES (IOLS) (P980040/S017)Johnson & Johnson Surgical Vision, Inc.2007-08-30
INTACS PRESCRIPTION INSERTS (P980031/S007)Addition Technology2007-08-21
HEALON, HEALON GV AND HEALON5 SODIUM HYLAURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S031)Johnson & Johnson Surgical Vision, Inc.2007-08-16
VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL (P040045/S001)Vistakon, Division of Johnson & Johnson Vision Car2007-08-14
CRYSTALENS? MODELS AT-50SE AND AT-52SE ACCOMMODATING INTRAOCULAR LENSES (IOLS) (P030002/S010)Bausch & Lomb, Inc.2007-07-26
NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR UP TO 30 NIGHTS CONTINUOUS WEAR (P010019/S006)Alcon Laboratories, Inc.2007-07-26
TECNIS FOLDABLE ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003 (P990080/S024)Johnson & Johnson Surgical Vision, Inc.2007-07-16
STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM (P930016/S025)Amo Manufacturing USA, LLC2007-07-11
AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (P980040/S016)Johnson & Johnson Surgical Vision, Inc.2007-07-10
TECNIS ACRYLIC IOLS (P990080/S025)Johnson & Johnson Surgical Vision, Inc.2007-07-10
REZOOM MULTIFOCAL INTRAOCULAR LENSES (IOLS) (P960028/S022)Johnson & Johnson Surgical Vision, Inc.2007-07-10
EYEONICS CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S009)Bausch & Lomb, Inc.2007-06-29
ACRYSOF SINGLE PIECE INTRAOCULAR LENSES (P930014/S019)Alcon Laboratories, Inc.2007-06-15
UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (IOLS) (P880081/S033)Johnson & Johnson Surgical Vision, Inc.2007-06-07
ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S021)Johnson & Johnson Surgical Vision, Inc.2007-06-07
HEALON SODIUM HYALURONATE VISCOELASTIC PRODUCTS (P810031/S034)Johnson & Johnson Surgical Vision, Inc.2007-06-06
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S011)Bausch & Lomb, Inc.2007-05-25
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S008)Bausch & Lomb, Inc.2007-05-24
SOFTLENS (POLYMACON) CONTACT LENS (N16895/S089)Bausch & Lomb, Inc.2007-05-17
STAAR SURGICAL ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE THREE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S022)Staar Surgical Co.2007-05-16
CEEON HSM UV LIGHT ABSORBING PMMA ANTERIOR CHAMBER IOLS (P880070/S012)Abbott Medical Optics, Inc.2007-05-08
CEEON MODELS 911A AND 913A, TECNIS MODELS Z9000 AND Z9001 (P990080/S023)Johnson & Johnson Surgical Vision, Inc.2007-05-08
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011)Rayner Intraocular Lenses , Ltd.2007-05-03
CEEON AND TECNIS POSTERIOR CHAMBER INTRAOCULAR LENS (IOLS) (P990080/S008)Johnson & Johnson Surgical Vision, Inc.2007-05-01
SURGICAL COLLAMER UV-ABSORBING POSTERIOR IOL (P990013/S009)Starr Surgical Co.2007-05-01
ACRYSOF IQ MODEL SN60WF POSTERIOR CHAMBER INTRAOCULAR LENS (P930014/S017)Alcon Laboratories, Inc.2007-04-27
REZOOM MULTIFOCAL IOLS (P960028/S020)Johnson & Johnson Surgical Vision, Inc.2007-04-26
TECNIS ACRYLIC IOLS (P990080/S021)Johnson & Johnson Surgical Vision, Inc.2007-04-26
REZOOM MULTIFOCAL IOLS (P960028/S019)Johnson & Johnson Surgical Vision, Inc.2007-04-26
TECNIS ACRYLIC IOLS (P990080/S022)Johnson & Johnson Surgical Vision, Inc.2007-04-26
SENSAR ACRYLIC INTRAOCULAR LENSES (IOLS) (P980040/S013)Johnson & Johnson Surgical Vision, Inc.2007-04-26
SENSAR ACRYLIC INTRAOCULAR LENSES (IOLS) (P980040/S014)Johnson & Johnson Surgical Vision, Inc.2007-04-26
WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P030008/S005)Alcon Laboratories, Inc.2007-04-09
WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P020050/S005)Alcon Laboratories, Inc.2007-04-09
STAAR SURGICAL SILICONE INTRAOCULAR LENSES (P880091/S021)Staar Surgical Co.2007-03-29
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S011)Starr Surgical Co.2007-03-28
STAAR SURGICAL SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P880091/S020)Staar Surgical Co.2007-03-26
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S010)Starr Surgical Co.2007-03-23
AMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS) (P980040/S011)Johnson & Johnson Surgical Vision, Inc.2007-03-22
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S008)Starr Surgical Co.2007-03-22
STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER 1-PC AND 3-PC INTRAOCULAR LENSES (P990013/S012)Starr Surgical Co.2007-03-22
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S006)Starr Surgical Co.2007-03-22
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S007)Starr Surgical Co.2007-03-21
AMO SOFT ACRYLIC MULTIFOCAL IOLS (P960028/S017)Johnson & Johnson Surgical Vision, Inc.2007-03-21
AMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS) (P980040/S012)Johnson & Johnson Surgical Vision, Inc.2007-03-20
AMO TECNIS ACRYLIC LENS, MODEL ZA9003 (P990080/S020)Johnson & Johnson Surgical Vision, Inc.2007-03-20
AMO SOFT ACRYLIC MULTIFOCAL IOLS (P960028/S018)Johnson & Johnson Surgical Vision, Inc.2007-03-20
AMO TECNIS ACRYLIC LENS, MODEL ZA9003 (P990080/S019)Johnson & Johnson Surgical Vision, Inc.2007-03-20
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