BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    AcQMap High Resolution Imaging and Mapping System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517629197·CoRoent Ant TLIF Ti, 11x12x34mm 15°

    3212345

    FDA Adverse Event
    Malfunction ·July 8, 2013

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970508·

    NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DISTAL VOLAR RADIUS PLATING SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    UNITIP CATHETER FOR HR GI

    FDA Adverse Event
    Malfunction ·UNISENSOR USA INC·Product code FFX·January 16, 2015

    BAIR HUGGER / 3M

    FDA Adverse Event
    Injury ·3M·Product code DWJ·November 23, 2016

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017