BEUDAMED
    16 results · 41ms · Sources: EU EUDAMED, US FDA

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    IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COMPREHENSIVE LOCKING SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019

    UCR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYDROCOLOR 5

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    ALIGN R URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·May 16, 2013

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Other ·MERZ AESTHETICS, INC.·Product code LMH·June 9, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORPORATION·Product code NBW·August 22, 2008

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023