BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    T:FLEX INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·April 16, 2019

    INTERLOCK FIBERED IDC OCCLUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOPRO 225 DUAL HALOGEN LIGHT SOURCE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    FDA Adverse Event
    Other ·D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INTERNATIONAL·Product code FRZ·January 5, 2012

    FUJIFILM ENDOSCOPE MODELS EC-760R-V/M

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDF·March 25, 2024

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 17, 2013

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 22, 2011

    NEPHROMAX KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code EZN·September 19, 2008

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    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