BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    DCA VANTAGE, MODEL 5075

    FDA 510(k)
    FDA Class 2 ·Hematology

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489125563·PowerChem Neoprene Exam Gloves, Extra Extra Large

    QED DIODE DETECTORS, MODELS 1112-1116

    FDA 510(k)
    FDA Class 2 ·Radiology

    VOCOM SILICONE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    RENAISSANCE 26 STRETCHR 11/00

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 22, 2013

    SLS II

    FDA Adverse Event
    Death ·SPECTRANETICS CORP.·Product code MFA·June 19, 2008

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 28, 2011

    Allura Xper FD20; Model Number: 722006;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·January 21, 2026

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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