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

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    InThrill Thrombectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LONG SCREWDRIVER WITH T-HANDLEFOR CLICK'X® LOCKING CAP

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HXX·November 15, 2017

    AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNSPAR ADVANCED

    FDA 510(k)
    FDA Class 2 ·Dental

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 5, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026