BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    ANKYLOS SYNCONE ABUTMENT 5(DEGREE)

    FDA 510(k)
    FDA Class 2 ·Dental

    BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    QUANTA FLASH H-TTG IGG

    FDA 510(k)
    FDA Class 2 ·Immunology

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

    STEM: AMISTEM H HA COATED LAT STEM SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 30, 2020

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    EPICARDIAL PATCH

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code LWS·June 16, 2011

    ELECSYS TSH ASSAY

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JLW·November 9, 2020

    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