BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    aBSI

    FDA 510(k)
    FDA Class 2 ·Radiology

    MR CARDIAC FUNCTION ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLEXI-LITE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD BACTEC; PLUS AEROBIC/F CULTURE VIALS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 19, 2021

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·July 27, 2011

    PERMANENT CAUTERY HOOK INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 26, 2008

    BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·April 22, 2020

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022