BEUDAMED
    15 results · 32ms · Sources: EU EUDAMED, US FDA

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    MULTIX SELECT DR

    FDA 510(k)
    FDA Class 2 ·Radiology

    MPS ACACIA SAFEGUARD HUBER DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFRARED EAR THERMOMETER, MODEL IR-04MT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·April 11, 2014

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    NI

    FDA Adverse Event
    Malfunction ·NI·Product code FPA·March 8, 2017

    ACCU-CHEK ® PERFORMA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·October 1, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    LUCAS MEDICAL NON-LATEX EMBOLECTOMY CATHETER

    FDA Adverse Event
    Malfunction ·LUCAS MEDICAL, INC.·Product code DXE·June 17, 2011

    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