BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    MROZ REVERSE OSMOSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694043724·LPM Mesh, 187mm x 161mm x 0.6mm, Rigid

    WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 17, 2013

    SENSIA SR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·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