BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    SAS SALMONELLA H Z38 ANTISERUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BASE

    FDA UDI
    Nuvasive, Inc.·00887517701787·BASE Ti Bolt, 5.0x22.5mm Fixed

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690128830·Revision Fluted Stem 22mm x 100mm

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221118165·3M™ Victory Series™ Second Molar Bands, 955-221...

    R82

    FDA UDI
    R82 A/S·05707292803184·

    AlphaVent

    FDA UDI
    STRYKER CORPORATION·07613327563245·ALPHAVENT SUTURE ANCHOR 5.5MM PEEK, SUTURE ANCH...

    TOX/SEE DRUG SCREEN

    FDA Adverse Event
    Death ·BIO-RAD LABORATORIES INC·Product code DIO·January 17, 2014

    SPECIAL BOND II

    FDA 510(k)
    FDA Class 2 ·Dental

    SERATEST RF (HEMAGGLUTINATION) KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    32MM M2A HI CARBON HEAD +3MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWY·February 11, 2013

    SPL LEAD, TRANSVENOUS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    ASPHERE M SPEC 12/14 36 -2

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.8010379·Product code KWA·July 24, 2014

    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