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

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    PRODESSE PROFLU+ ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NexxZr™ T / D-100-25-NT-C300-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113399·

    LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITRONIX MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RADIUS 018 COUGAR WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITROS 250 CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·September 16, 2014

    ALERE CHOLESTECH LDX MULTIANALYTE CONTROLS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JJY·October 2, 2015

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 16, 2009

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HAV IGM REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LOL·June 17, 2011

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·August 21, 2008

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 18, 2015

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·June 3, 2016

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·December 2, 2015

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 2, 2016

    UNSPECIFIED BD TUBING SET

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·December 2, 2020

    Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

    FDA Enforcement
    Class II ·Ongoing·Getinge Usa Sales Inc·October 11, 2023

    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016