BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER

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

    PBS(-), Phosphate Buffered Saline

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

    PRODUCT #K3002 KETOTROL-N(URINE CONTROL)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HP ERGO, UNKNOWN PEN BODY TYPE

    FDA Adverse Event
    Injury ·ELI LILLY AND COMPANY·Product code NSC·June 10, 2014

    COAGUCHEK® XS SYSTEM

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

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 6, 2012

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·September 23, 2024

    HEARTMATE 3 LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·March 3, 2025

    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