BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRODUCTION SYSTEMS, INC.

    FDA registration
    PRODUCTION SYSTEMS, INC.·1 product·🇺🇸 United States

    MED-RX EXTENSION SET WITH T-CONNECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HDS HI 1.54

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·Product code OYC·June 21, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·July 8, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·November 10, 2021

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·January 15, 2026

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024