BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131260703·H11, MINIRITE 312 WL CBE

    LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

    FDA 510(k)
    FDA Class 2 ·Radiology

    INBONE TOTAL ANKLE SYSTEM MODEL 200347902

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEUTRAL POLY LINER 36MM SET

    FDA Adverse Event
    Malfunction ·ZIMMER MANUFACTURING B.V.·Product code JWH·April 24, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    ECHELON 60 ENDOPATH

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 20, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 29, 2013

    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