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

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    MODEL 43130A DEFIBRILLATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209119417·KIT, CCRK SQUAD - CUSTOM

    PathLoc-C Posterior Cervical Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RTP-5000

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCLAIM ENCORE 2.25

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 4, 2014

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 5, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·November 30, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026