BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    RELIENT NAVIGATION DEVICE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FOWLER ENDOCURETTE, MODEL CUR-XXX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 13, 2025

    MITEK OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·April 16, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·March 14, 2011

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·June 12, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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