BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Reveal

    FDA UDI
    Oticon A/S·05707131342867·G20, MINIRITE T 312 2.4G C090 REVEAL

    R650 QDASM COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER

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

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code NVN·January 13, 2014

    KARL STORZ

    FDA Adverse Event
    Malfunction ·KARL STORZ GMBH & CO. KG·Product code GEI·June 14, 2013

    ARCHITECT C-PEPTIDE REAGENTS

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JKD·August 5, 2011

    GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Brivo MR355, Optima MR360, GE 1.5T SIGNA HDE MR SYSTEM, Signa Openspeed 0.7T MR SYSTEM, Vectra, SIGNA 0.35T OVATION WITH EXCITE, SIGNA 0.2T PROFILE With EXCITE MRI Systems

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 1, 2015