BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    BETA QUIK V

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    pREBOA-PRO Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVERBOND GLASS IONOMER CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    STOCKERT S5 SYSTEM

    FDA Adverse Event
    Other ·SORIN GROUP DEUTSCHLAND·Product code DTQ·May 27, 2014

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL MD, INC.·Product code JOH·October 25, 2012

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·September 10, 2010

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018