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

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    Twin-Pass Torque

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UTA AND UHA

    FDA 510(k)
    FDA Class 2 ·Dental

    DURAGEN PLUS - ADHESION BARRIER MATRIX 10.0 CM X

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·January 11, 2018

    DURAGEN PLUS - ADHESION BARRIER MATRIX 10.0 CM X

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·January 10, 2018

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code NIK·October 10, 2014

    MEDRAD VERIS MR VITAL SIGNS MONITOR

    FDA Adverse Event
    Malfunction ·MEDRAD·Product code MHX·June 6, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    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