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

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    TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    REMEL

    FDA UDI
    REMEL, INC.·00848838006036·BHI Broth w/6.5% NaCl (5ml) 20/PK

    TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BRAHMS DIAGNOSTICA LUMITEST ANTI-TG

    FDA 510(k)
    FDA Class 2 ·Immunology

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 12, 2018

    TRIAGE CARDIAC HS PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 22, 2019

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code MMI·May 18, 2018

    TRIAGE CARDIAC PANEL KIT

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code JHX·April 18, 2018

    TRIAGE CARDIAC HS PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·October 21, 2019

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·October 5, 2017

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 16, 2013

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·June 10, 2008

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·April 15, 2011

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·November 1, 2018

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    FDA Adverse Event
    Injury ·ALERE SAN DIEGO, INC.·Product code MMI·May 17, 2017

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012