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

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    DELUXE HEAT WRAP/COLD WRAP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58208010810·RETRACTOR, ALL TYPES

    ACUMED

    FDA UDI
    Acumed LLC·10806378046353·Ulnar Head Surface Reamer Coupler

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·10842209112927·

    ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 7, 2024

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Malfunction ·Product code NBW·May 8, 2014

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD - 8010379·Product code KWA·October 23, 2012

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 21, 2007

    BD¿ IV SET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·May 22, 2018

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    dS Breast 16ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021