BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES

    FDA 510(k)
    FDA Class 2 ·Immunology

    SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEMOMETAL INTRA-MEDULLARY BONE FASTENER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·October 23, 2017

    HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS

    FDA Adverse Event
    Malfunction ·STERILMED, INC.·Product code NLQ·July 27, 2021

    IAB: 8 FR - 40 CC FOS

    FDA Adverse Event
    Injury ·ARROW INTERNATIONAL INC·Product code DSP·May 17, 2013

    S4S/SUR-FIT NATURA 2 PC - 2 PC STOMAHESIVE (SH) WAFER W/ FLEXIBLE COLLAR

    FDA Adverse Event
    Injury ·CONVATEC, INC.·Product code EXE·September 17, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 13, 2011

    CODA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·September 10, 2019

    Cardio Vascular-Allura Centron, system code 722400

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025