BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOL-M™ Hypodermic Needle

    FDA UDI
    Sol-Millennium Medical, Inc.·00818392015171·Sterile hypodermic needles intended to inject f...

    TOTAL SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 14, 2013

    INTERA 1.5T

    FDA Adverse Event
    Injury ·PHILIPS HEALTHCARE·Product code LNH·September 17, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·May 25, 2011

    Depuy LCS Complete RP insert; polyethylene tibial insert STD+, 17.5 mm; Ref 1294-05-517.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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