BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    Focus HD 35 Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180124486·5 MM DIA., 36 CM INSULATED SPATULA TIP ELECTROD...

    ROSE K POST GRAFT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EMORY CARDIAC TOOLBOX 4.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    RAD-G

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024

    MICROAIRE

    FDA Adverse Event
    Malfunction ·MICROAIRE SURGICAL INSTRUMENTS·Product code HWC·September 26, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 9, 2013

    CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE: SYNTHES USA PRODUCTS LLC·Product code HXX·December 29, 2017

    CANNULATED STARDRIVE SCRWDRVR SHAFT FOR 3.0MM HCS T8

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HXX·May 12, 2016

    COMPOSIX MESH EX

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 17, 2012

    CANNULATED STARDRIVE SCREWDRIVER SHAFT FOR 3.0MM HCS T8

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HXX·September 25, 2014

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019