BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    CarbonCool® System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257126080·30-40 MV FOR MEN CLSC CALF STD BRN III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257142639·30-40 MFW VITALITY CALF CT CHOC III

    BD BBL™ Streptocard™ Enzyme Positive Control

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902409335·BD BBL™ Streptocard™ Enzyme Positive Control, o...

    Arthroscopy sheath

    FDA UDI
    SOPRO-COMEG GmbH·04059082032900·

    ALIVECOR HEART MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ECAT HRRT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    QT SCANNER 2000 MODEL A

    FDA Adverse Event
    Injury ·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·November 4, 2014

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 9, 2011

    TI MULTI VECTOR DISTRACTOR ASSEMBLY/LEFT WITH 35MM ARMS

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code DZL·July 22, 2013

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018