BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    IQon Spectral CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    HHM

    FDA UDI
    Oticon A/S·05707131342942·G200, MINIRITE 312 2.4G C091 HHM

    14 WIRE STANDARD, 14 WIRE LS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SONOSITE EDGE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 23, 2025

    LINOX SMART SD 65/16

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·June 27, 2013

    GPS STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FPO·October 8, 2008

    SPINAL ANESTHESIA KIT

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code BSP·July 13, 2011

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024