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

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    EYESEECAM VHIT

    FDA 510(k)
    FDA Class 2 ·Neurology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694055413·1.6mm Orbital Floor Plate, Preformed, Left, .2m...

    STERISIL ANTIMICROBIAL TUBING AND BOTTLE

    FDA 510(k)
    FDA Class 1 ·Dental

    TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015

    GLADIATOR¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 6, 2012

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·May 29, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TOP END·Product code IOR·October 1, 2014

    LOCK-CLIP F/RIA

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·June 7, 2013

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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