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

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    SHIMADZU X-RAY TUBE STAND BH-100 SERIES

    FDA 510(k)
    FDA Class 1 ·Radiology

    SPECTACLE FRAME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALTEON HIP COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code LPH·October 16, 2025

    4D DC SENSOR MEDIUM

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·June 20, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 22, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021