BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SHENZHEN MED-LINK PULSE OXIMETER PROBE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CANTATA 2.9 SUPERSELECTIVE MICROCATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·September 14, 2017

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·May 29, 2013

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·October 1, 2014

    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