BEUDAMED
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    K.D. CHIN IMPLANT

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

    ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT; ENDOVIVE LOW PROFILE BUTTON REPLACEMENT GASTROSTOMY TUBE; SECURI-T INITIAL P

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

    ST-4 COAGULATION INSTRUMENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·December 3, 2010

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Death ·PHYSIO-CONTROL, INC·Product code LDD·July 3, 2014

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·December 6, 2012

    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