BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    SMITH AND DAVIS PRESSURE THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450560518·

    PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CASPIAN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRILL F.RADIOLUCENT TARGETING DEVICE SIDEWINDER Ø3,2 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·September 16, 2013

    CIRCULAR STAPLER 25MM

    FDA Adverse Event
    Injury ·ETHICON ENDOSURGY·Product code GDW·June 30, 2014

    RECONSTITUTION DEVICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FRN·December 3, 2010

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·November 9, 2012

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015