BEUDAMED
    11 results · 25ms · 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 ×

    IRIS - HIGH STRENGTH GLASS CERAMIC

    FDA 510(k)
    FDA Class 2 ·Dental

    GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

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

    ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 21, 2023

    MAGELLAN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH·Product code FMI·March 6, 2026

    INTERCHANGEABLE ULNAR ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQL·May 17, 2013

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·September 26, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 14, 2011

    INTERCHANGEABLE HUMERAL ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018