BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

    FDA 510(k)
    FDA Class 2 ·Hematology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450306611·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450053324·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450572108·

    M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180507513·Curette, Teardrop, Angled, Straight, Smooth, Si...

    PM9000 MONITOR

    FDA Adverse Event
    Malfunction ·SHENZHEN BIOMEDICAL ELECTRONICS CO.·Product code MHX·April 30, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 20, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 17, 2011

    Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·June 8, 2016