BEUDAMED
    11 results · 26ms · Sources: EU EUDAMED, US FDA

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    MONOSTERYL

    FDA 510(k)
    FDA Class 1 ·Dental

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471121935·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 125mm

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867138766·UNIVERS BROACH MISA 5MM

    OTT INSUFFLATION FILTER TUBING

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DSL ACTIVE ALDOSTERONE (DSL 8600)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    URETERO-RENO VIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FGB·July 16, 2015

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·January 15, 2013

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·April 17, 2025

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021