BEUDAMED
    19 results · 34ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    FIBER OPTICS SIGMOIDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PHENOBARBITAL ANALYTICAL TEST PACKS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    P.004 ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·May 23, 2018

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·April 27, 2018

    MALLINCKRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTS·June 21, 2011

    MALLINKCRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCHOHEALTHCARE·Product code BTS·September 30, 2010

    MALLINKCRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTS·September 30, 2010

    MALLINKCRODT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTS·September 30, 2010

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code CBI·June 16, 2011

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·October 9, 2017

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·November 13, 2017

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W.L. GORE & ASSOCIATES·Product code MIH·April 25, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·June 29, 2007

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·September 28, 2012

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·November 19, 2018

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·July 14, 2017

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·MALLINCKRODT MEDICAL·Product code BTS·April 2, 2018

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021