BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    PROFEMUR TL2 Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019

    ZEVO ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018

    SPK SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    METAFLEXCOIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    TRANSPORT SERIES OBS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 1, 2011

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 26, 2013

    LASSOSTARNAV,10P,15MM DIA LOOP

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·February 22, 2023

    LASSOSTAR CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER INC.·Product code DRF·December 30, 2020

    LASSOSTAR NAV CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·November 23, 2022

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018