BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    FALCON IVF FOUR WELL PLATE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Monolith

    FDA UDI
    Nuvasive, Inc.·00887517677082·Monolith Core, Ø12x49mm

    SECUTEX WRIST BRACE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CARESCAPE B450

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·June 11, 2009

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·March 6, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·August 8, 2014

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·February 15, 2011

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020