BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)

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

    MERLIN SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARI-PATH SURGICAL NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 6, 2014

    STAR TOTAL ANKLE REPLACEMENT

    FDA Adverse Event
    Injury ·SMALL BONE INNOVATIONS, INC.·Product code HSN·July 16, 2013

    BODY/STEM SEPARATOR

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·November 18, 2015

    BD ULTRASAFE PLUS X100L PNG CLEAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON HUNGARY KFT (BD)·Product code MEG·July 3, 2019

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025