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

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    CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE

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

    SYNGO.VIA WEB VIEWER

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 1, 2014

    MEDICHOICE

    FDA Adverse Event
    Injury ·DALIAN GOODWOOD MEDICAL CARE LTD.·Product code HGD·May 23, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 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