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

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    CONFIRM BIOACTIVE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

    FDA Adverse Event
    Injury ·THE SPECTRANETICS CORPORATION·Product code DQY·March 6, 2019

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 29, 2013

    GE OEC 9600

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

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·June 9, 2011

    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