BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CADD

    FDA UDI
    ICU MEDICAL, INC.·10610586033780·

    ARROW REVERSE SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMC ANTIMICROBIAL PIN/WIRE SLEEVE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADD

    FDA UDI
    ICU MEDICAL, INC.·10610586042720·

    CADD

    FDA UDI
    ICU MEDICAL, INC.·10610586045387·

    PharmGuard

    FDA UDI
    ICU MEDICAL, INC.·15019517081282·

    INTELLIVUE MX800 PATIENT MONITOR

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 15, 2019

    UNKNOWN DEPUY FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. - 1818910·Product code KXA·October 30, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    COULTER® LH 750 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 9, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023