BEUDAMED
    9 results · 23ms · 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.
    Filters Regulation: Us FDA ×

    Electric Breast Pump

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

    U & I AMERICA SPINAL HOOK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·November 6, 2019

    ALARIS SYSTEM ETCO2 MONITOR

    FDA Adverse Event
    Injury ·CARDINAL HEALTH ALARIS PRODUCTS·Product code CCK·November 13, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    BARD FLAT MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·July 12, 2013

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·September 26, 2018

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022