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

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    SYNGO CT SINGLE SOURCE DUAL ENERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    BRAIN PERFUSION OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·April 5, 2019

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·April 5, 2019

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·April 5, 2019

    CORMET RESURFACING

    FDA Adverse Event
    Other ·CORIN LTD·Product code LZO·May 23, 2013

    MODEL NOT SPECIFIED

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·June 9, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    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