BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    ANTI-DS/N-DNA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776123871·Bipolar Forcep, bayonet,

    INVISALIGN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    RIGID GAS PERMEABLE CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VANGUARD XP E1 ANTIOXIDANT INFUSED RIGHT LATERAL TIBIAL BEARING 9MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·May 20, 2019

    VANGUARD XP E1 ANTIOXIDANT INFUSED RIGHT MEDIAL TIBIAL BEARING 9MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·May 20, 2019

    VANGUARD XP INTERLOK FEMORAL COMPONENT WITH PEGS 62.5MM RIGHT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·May 20, 2019

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 4, 2014

    ENDURANT STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·October 23, 2012

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·May 26, 2015

    XP-XP Tibial Tray - Interlok 63 mm Item # 195751

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013