BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    Black Diamond Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 30, 2008

    INTELLIVUE INFO CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 22, 2014

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 27, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 5, 2011

    DISPOSABLE LARYNGEAL TUBE, DUAL LUMEN

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTR·April 12, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023