BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    AQUILION ONE VISION, V6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814190·GENUMEDI PT SILVER L II

    ULTIMATE VIT ENHAMCER (UVE)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IMMUNOCARDSTAT HPSA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

    FDA Adverse Event
    Malfunction ·FOCUS DIAGNOSTICS, INC.·Product code OCC·December 29, 2014

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·May 29, 2013

    V-LOC 90 ABS CLOS DEVICE 3-0 CL 18 P-12

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GAM·June 14, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI PLANT - ST. PAUL·Product code LWS·October 1, 2014

    ENTERAL FEEDING ADAPTER

    FDA Adverse Event
    Injury ·COOK INC·Product code KGZ·December 7, 2015

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015