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

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    Alma Harmony

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO SUTURE CLINCH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·April 5, 2025

    . FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 20, 2011

    INFUSOMAT SPACE - US VERSION

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FPA·July 10, 2013

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025