BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    2MP COLOR LCD MONITOR, RADIFORCE MX215

    FDA 510(k)
    FDA Class 2 ·Radiology

    NC Cementable Abutment

    FDA UDI
    BIO CONCEPT Co., Ltd.·06947600305811·

    Biogel

    FDA UDI
    Bosma Enterprises·10818634023633·Biogel Optifit Ortho Surgical 9.0 - 40 Pair/Box

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019315057267·

    EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO XIA STAINLESS STEEL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 12, 2014

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·February 12, 2014

    OT ULTRALINK METER

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

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 16, 2011

    ADVANCE

    FDA Adverse Event
    Injury ·DATEX-OHMEDA·Product code BSZ·May 23, 2013

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·November 7, 2012

    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