BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    FIRECR DENTALIMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Plateau C

    FDA UDI
    Life Spine, Inc.·00190837093723·

    V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...

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

    PBN GUIDEWIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HLTHCARE CORP·Product code FRN·June 26, 2015

    ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL·Product code FZP·May 10, 2013

    PRISM HCV

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MZO·October 1, 2014

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 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