BEUDAMED
    7 results · 17ms · 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.

    PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS

    FDA 510(k)
    FDA Class 1 ·Dental

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·June 30, 2014

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 8, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 12, 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