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

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    Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A

    FDA 510(k)
    FDA Class 2 ·Radiology

    Richard-Allan® Needle 1/2 Circle Reverse Cutting

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00840113215508·Intent to be used with suture material for tiss...

    SCANLAN® V.I.P™ Instrument Sterilization Trays

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159032116·A/V Punch Tray

    MODIFICATION TO: ECAT LSO PET/CT SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEKA SMARTXIDE AND DELIVERY ACCESSORIES

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

    HEMASHEILD PLAT WOVEN DOUBLE VELOUR GRAFT

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR LLC·Product code MAL·October 27, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 16, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·July 3, 2013

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021