BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO:EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·July 11, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 11, 2013

    CONQUEST PRO 12 ST

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·July 16, 2025

    ASTATO XS 9-12

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·June 24, 2025

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014