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

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    Filters Regulation: Us FDA ×

    Assert-IQ™ Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464030255·OTICON MORE 3 MINIRITE T C091

    TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STREAMLINE MIS SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2020

    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

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·October 21, 2016

    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

    RSP

    FDA Adverse Event
    Other ·ENCORE MEDICAL, L.P.·Product code HSD·November 7, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 16, 2013

    TRIAGE CARDIAC TRIPLE MARKER PANEL

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

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·April 18, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    TRIAGE CARDIAC TRIPLE MARKER PANEL

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