BEUDAMED
    10 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.
    Filters Regulation: Us FDA ×

    StatStrip Glucose Hospital Meter System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112601·BARRON CORNEAL PUNCH 7.25MM

    CONDUCTIVITY STANDARD SOLUTION-METERCARE

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

    PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (US SURGICAL)·Product code GEI·November 7, 2008

    COLLEAGUE

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

    PROSTHESIS, KNEE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·July 17, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025