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

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    Portex Blue Line Ultra Paediatric Tracheosomy Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HUMERAL NAIL

    FDA UDI
    Biomet Orthopedics, LLC·00887868004834·

    K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MONTERIS MEDICAL NEUROBLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015

    LIFEPAK(R) 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code LDD·June 14, 2013

    PIC 50

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·June 23, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIQ·September 15, 2008

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025