BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT

    FDA 510(k)
    FDA Class 2 ·Radiology

    REVELATION DIAMOND

    FDA UDI
    Ss White Burs, Inc.·D6909122252·REVELATION DIAMOND 835-014M - 5 PACK

    Gen. Acces/ Instr. Tip Guard

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110867·TIP GUARDS VENTED BLUE PACK OF 100

    SUNTANNING DEVICE (SEPAR. FROM K812225)

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

    SORIN CENTRIFUGAL PUMP 5 (CP5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTAIN 6215 VENOGRAM BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·January 11, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·November 18, 2010

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2014

    CP5 FLOW MODULE

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWA·July 18, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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