BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    FiberTak® Suture Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978948881·INSTRUMENT 8231330 CANNULATED TAP 5.5MM

    TP Original Wire

    FDA UDI
    TP ORTHODONTICS INC·00192029028841·Premier Plus Round

    MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    QUARTET

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 6, 2014

    NEW LIGASURE 5MM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 25, 2011

    ATRION QL38 LOCKING SYRINGE

    FDA Adverse Event
    Death ·ATRION MEDICAL PRODUCTS, INC.·Product code MAV·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022