BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    JACKET & SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Little Wave Arc; Little Wave Flip

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BARCO MEDIS 5MP2 AURA

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 28, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·August 7, 2008

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 2, 2010

    Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test

    FDA Enforcement
    Class II ·Ongoing·Microbiologics Inc·February 19, 2025

    Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 16o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-06-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-06-23, c) 44, 47, 50, 53 head, Large, Item Number 314-06-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-06-25; Shoulder Arthroplasty

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