BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    PRESSURE INFUSOR #1900

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Swan Ganz Catheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LYSUS INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code PHX·July 15, 2024

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·April 3, 2025

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 7, 2010

    MAMMOMARK BIOPSY IDENTIFIER

    FDA Adverse Event
    Malfunction ·DEVICOR MEDICAL PRODUCTS INC.·Product code NEU·November 21, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012