BEUDAMED
    35 results · 32ms · Sources: EU EUDAMED, US FDA

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    FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Conformis Hip System

    FDA UDI
    Conformis, Inc.·00810933030025·REAMER, ACETABULAR, 47MM FULL

    SONIC, MODEL SO-100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017

    OPEN HEART PACK WITHOUT PLEGIOX BEQ-TOP 40010

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·May 5, 2017

    CARDIAC SURGERY PACK BO-TOP 36500

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·March 28, 2017

    CUSTOM TUBING PACK

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017

    CUSTOM TUBING PACKS

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 26, 2013

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·April 22, 2011

    PRGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 22, 2008

    BO-TOP 36500 QUADROX OXYGENATOR

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·November 14, 2017

    REBOUND HRD

    FDA Adverse Event
    Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

    CUSTOM TUBING PACK

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·February 1, 2017

    CUSTOM SURGERY PACK BO-TOP 36500/ QUADROX

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·September 28, 2017

    BEQ-TOP 5210 ECC PACK

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·November 9, 2017

    CUSTOM PACK BO-T 25102

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017

    CUSTOM TUBING PACK BO TOP 25102

    FDA Adverse Event
    Malfunction ·DATASCOPE FAIRFIELD·Product code DWE·March 31, 2017

    Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

    FDA Enforcement
    Class III ·Terminated·Spinal Elements, Inc·May 15, 2013