BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    GlucoSure ADVANCE Link Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 3, 2024

    OEC 9900 ELITE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·January 23, 2020

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 24, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·August 20, 2024

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·November 18, 2024

    TRUETRACK

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·July 17, 2019

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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