BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·May 24, 2017

    TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc (AMO)·March 20, 2013

    Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·May 17, 2017

    Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·May 17, 2017

    Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·May 17, 2017

    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc (AMO)·December 17, 2014

    Healon V, Part No. 10290045

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·May 17, 2017

    Healon 5 Pro, Part No. 10270015

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·May 17, 2017

    Healon Pro, Part No. 10270012

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·May 17, 2017

    Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

    FDA Enforcement
    Class II ·Terminated·Irvine Biomedical Inc, a St. Jude Medical Co.·September 30, 2020