BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    AMBU OXYGEN REGULATOR

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Printed Lower Crown Pack for Herbst LL7 12mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199016230·

    Stern EX Acid Etched Implant RP 3.75x13.0mm, DD, Biomain, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549108648·The Sterngold Acid Etch Dental Implant System c...

    SCULPTURE FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    LAMINOPLASTY FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·September 10, 2025

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 7, 2014

    UNKNOWN NECK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 3, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·November 10, 2010

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021