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

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    MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Leksell Vantage Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201501924·GUIDE SLIDE

    CARDINAL HEALTH

    FDA UDI
    Cardinal Health 200, LLC·10885425494873·DEBRIDEMENT TRAY

    LYNX

    FDA UDI
    HNM TOTAL RECON LLC·00841742110691·LYNX ø3.5mm Std Cortical Screw, Full Thread, Se...

    COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK, CEFAZOLIN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 5, 2011

    SMALL TORQUE WRENCH

    FDA Adverse Event
    Injury ·OMNLIFE SCIENCE, INC.·Product code KWQ·April 3, 2013

    PFC SIGMARP CV TB/IN S3 10.0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, DEPUY-CORK DIVISION·Product code NJL·May 7, 2008

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013