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

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    GYRUS PLASMACISION LAPAROSCOPIC SPATULA

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

    ECAT VISION PET SCANNER, MODELS 3000 & 5000

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MRG·August 14, 2013

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·September 18, 2013

    ADVIA CENTAUR TSH3-ULTRA (TSH3-UL)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code JLW·April 30, 2014

    CURVED MULTI-CUT SCISSORS (4BX)

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code GEI·April 8, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 6, 2011

    SELUTE PICOTIP LEAD

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    ADVIA CENTAUR XP

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code NHS·January 31, 2014

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024