BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    16 X 125 MM TEST TUBE, CATALOG #01-441

    FDA 510(k)
    FDA Class 1 ·Hematology

    CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOFIA(R) RSV FIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 21, 2015

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·January 22, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·November 24, 2010

    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015

    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014