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

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    CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925012073·GUILFORD STAPES KNIFE 7 MM BLADE LENGTH STAINLE...

    VLOC9ABSORBABLE WOUND CLOSURE DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NOBEL PERFECT IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR·Product code CBK·May 22, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 30, 2014

    SHILEY CUFFLESS FENESTRATED

    FDA Adverse Event
    Injury ·COVIDIE / FORMERLY TYCO HEALTHCARE·Product code JOH·June 13, 2011

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

    UNKNOWN VLOC PRODUCT

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 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