BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EXTERNAL FIXATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TENZCARE(TM) SNAP ELECTRODE 6867

    FDA 510(k)
    FDA Class 2 ·Neurology

    SENSIA

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 29, 2014

    SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021