BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

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    HEMOSIL FACTOR II DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    CT LUCIA

    FDA UDI
    CARL ZEISS MEDITEC PRODUCTION, LLC·00843045100829·3-piece, monofocal, hydrophobic, acrylic, intra...

    RANDOX PREALBUMIN

    FDA 510(k)
    FDA Class 1 ·Immunology

    MODIFICATION TO TISSUELINK BIPOLAR FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HI-TORQUE BALANCE MIDDLEWEIGHT GUIDEWIRE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code DQX·November 7, 2011

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 14, 2013

    EPIC II CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·March 14, 2011

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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