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

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    TelePatch Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131305558·SENSEI, BTE 312 WL 75 PUW TAR

    NEURO II-SE, MODELS OR-MB-DR AND OR-DR

    FDA 510(k)
    FDA Class 2 ·Radiology

    JOULE MULTI-PLATFORM SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 10, 2014

    LATEX SURGEON'S GLOVE

    FDA Adverse Event
    MEDLINE INDUSTRIES, INC.·Product code KGO·May 15, 2013

    BIOFINITY (COMFILCON A)

    FDA Adverse Event
    Injury ·COOPERVISION MANUFACTURING LIMITED·Product code LPM·July 11, 2011

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    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