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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    LVIVO EF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUSTAIN SPACE MAINTENANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    5F MEDTRONIC LAUNCHER GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPLACEMENT HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·May 24, 2013

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014

    ENRHYTHM DR

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