BEUDAMED
    11 results · 22ms · 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 ×

    Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARTHREX UNIVERS II SHOULDER PEGGED GLENOID

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDIHONEY UNKNOWN

    FDA Adverse Event
    Injury ·DERMA SCIENCES, INC.·Product code FRO·March 20, 2026

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 28, 2011

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

    PHOTOFIX PATCH - 6CM X 8CM

    FDA Adverse Event
    Injury ·CRYOLIFE, INC. - KENNESAW·Product code PSQ·January 12, 2021

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 23, 2019

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025