BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    TRIUMPH-1 PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490846967·INSTRUMENT 8951814 18 14MM SGL BARL DIST

    SERVO-U Ventilator System, SERVO-n Ventilator System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·February 9, 2013

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 2, 2014

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·January 7, 2011

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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