BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BI-METRIC HEAD/NECK HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304223066·

    SUPRACOR BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·October 7, 2014

    BOLT CUTTING HEAD Ø5 LONG CUTTING-H 2 F/

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXZ·June 11, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 14, 2011

    RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020