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

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    SOPHEIA DIGITOXIN EIA KIT & COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Total Foot System 2

    FDA UDI
    Smith & Nephew, Inc.·00885556838907·3.5MM PLATE LOCKING SCREW 35MM

    Integra® Total Foot System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780118503·The locking rearfoot screw is used in the Integ...

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471191785·SHAVER BLADE - RESECTOR 3.5MM

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209128198·KIT, FBTK DONOR MODULE w/o BLOOD BAG

    TSRH® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978050089·ROD 830-035 DANEK 1/4 UNIT L35CM

    Solution, Removal, Carries

    FDA Pre-Market Approval
    FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

    BioSci™ Disposable Virus Sampling Tubes

    FDA 510(k)
    FDA Class 1 ·Microbiology

    IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Solution, Removal, Carries

    FDA Pre-Market Approval
    FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

    Solution, Removal, Carries

    FDA Pre-Market Approval
    FDA Class 3 ·GK-101E CARIES REMOVAL AGENT/SYSTEM

    Solution, Removal, Carries

    FDA Pre-Market Approval
    FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

    PFNA BLADE PERF L120 TAN

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HSB·May 23, 2014

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·November 13, 2012

    BLADELESS VP 12MM ST W/ FIXATION

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL·Product code GCJ·September 3, 2010

    TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 5, 2017