BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cell-Free DNA BCT

    FDA UDI
    STRECK, INC.·30844509002254·Cell-Free DNA BCT is a direct-draw venous whole...

    OPHTEC ENCLAVATION NEEDLE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Infrared Thermometer Model Number RN-60A,RN-60B

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ALARIS PUMP MODUEL ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·October 22, 2014

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011

    TECNIS OPTIBLUE 1-PIECE

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·July 16, 2013

    CMD 25-1406 PROMADE ELBOW

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code JDC·March 12, 2026

    TEMA ELBOW

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDB·January 24, 2025

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    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