BEUDAMED
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    KITTNER DISSECTOR/PEANUT/CHERRY/STICK/TRIANGLE SPONGE/GAUZE ROSEBUD

    FDA 510(k)
    FDA Unclassified ·Unknown

    RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·June 26, 2014

    NEXGEN LPS ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·December 23, 2010

    NA

    FDA Adverse Event
    Injury ·Product code FTR·July 13, 2006

    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013