BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    INNOVISION-EXII

    FDA 510(k)
    FDA Class 2 ·Radiology

    Artman Instruments

    FDA UDI
    Wise Linkers, LLC·D1272421191·Periosteal Elevators Kit 10 pcs periosteum elev...

    MedDrain

    FDA UDI
    ARMM INC.·10850082007285·MedDrain 11mm Mediastinal Catheter 9 Eyes - Top...

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295122876·TOTAL KNEE REV REAMER 19mm

    POWDER-FREE VINYL PATIENT EXAMINTION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROCOTYL L-O ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 9, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

    Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field Safety Notice ( FSN MA-FCO79500316 ) QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are affected. Catalog # 795041 and Part # 989605315491 Designed to view and quantify image data acquired on Philips Healthcare ultrasound products.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·December 24, 2014