BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    OTS 25-L (100-5)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ODISSEY TISSUE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    11.0 CM LONG ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·November 10, 2014

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 18, 2011

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code MLM·July 22, 2013

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025

    Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014