BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    CARDIOVASCULAR SPRING GUIDES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHARNLEY FEMUR DRILL #1 AND #2

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

    SURESHOT Distal Targeting System V4.0 Trauma Interface

    FDA 510(k)
    FDA Class 2 ·Neurology

    COAGUCHEK S SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JPA·November 13, 2007

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 3, 2012

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·December 18, 2013

    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.

    FDA Recall
    Terminated ·Owen Mumford USA, Inc.·Product code FMF·December 11, 2014

    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026