BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    RING-LOK MODULAR BIPOLAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMPREHENSIVE LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019

    ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CYNOSURE PHOTOGENICA SV LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013

    AUTOPULSE RESUSCITATION SYSTEM

    FDA Adverse Event
    Injury ·ZOLL CIRCULATION·Product code DRM·June 9, 2011

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·April 9, 2014

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·April 9, 2014

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014