BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    Orthopedic Fixation Pin

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PYRENEES Cervical Plate System

    FDA UDI
    VB Spine LLC·10888857260498·Tap Size ø2.3mm x 16mm

    SMARTTRACK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEWPORT E360 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·October 1, 2008

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 28, 2011

    UNIDENTIFIED ASR CUP OR HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·June 26, 2013

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016