BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Dental

    VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Synapse 3D Liver and Kidney Analysis

    FDA 510(k)
    FDA Class 2 ·Radiology

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 52/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·August 2, 2023

    ACUMATCH M-SERIES MODULAR STRAIGHT STEM

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code LPH·November 21, 2008

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    IROX

    FDA Adverse Event
    Malfunction ·GUIDANT ANGLETON/ST. PAUL·Product code NVN·July 23, 2013

    XVWEB

    FDA Adverse Event
    Injury ·PLANET DDS·Product code LLZ·March 13, 2025

    SECOND OPINION

    FDA Adverse Event
    Injury ·PEARL INC.·Product code MYN·March 13, 2025

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025