BEUDAMED
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    CARDIAC CATHERIZATION KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·October 17, 2012

    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQO·September 28, 2012

    SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CONSERVE(R) PLUS CUP

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·December 3, 2010

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·January 14, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 3, 2014