BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    VITAJET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SuperVu Galilean 2.5x, at 46cm working distance

    FDA UDI
    Rudolf Riester GmbH·04045396160668·Riester binocular loupes are used to enlarge th...

    SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. HOMECARE PRODUCT, INC·Product code INI·February 14, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 18, 2011

    SIENTRA SILICONE GEL-FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·SIENTRA, INC·Product code FTR·July 15, 2014

    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

    FDA Recall
    Terminated ·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020