BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    OTC EMS STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COBAS INTEGRA BILIRUBIN DIRECT GEN.2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SHIRAZ-ANTERIOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMISTEM COLLARED HA COATED LAT STEM SIZE 3

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 27, 2024

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·May 29, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 20, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    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