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

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    RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    KITS AND TRAYS FOR ONE TIME USE ONLY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    IMMUCHEM NEONATAL TSH-MP ELISA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·June 13, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·January 15, 2013

    LIFEPAK CR PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 16, 2010

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·July 23, 2014

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    FDA Adverse Event
    Death ·HEARTWARE, INC.·Product code DSQ·August 1, 2022

    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