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

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    EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HHM

    FDA UDI
    Oticon A/S·05707131261212·H110, BTE 13 WL 85 CBE HHM

    CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RISE SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    INNOVA 2121 - IQ

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS S.C.S.·Product code MQB·June 15, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code IOR·May 29, 2013

    CLINICAL INFORMATION CENTER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DSI·August 22, 2008

    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