BEUDAMED
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    ACCU-CULT FECAL OCCULT BLOOD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    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

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 30, 2014

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM

    FDA Adverse Event
    Injury ·SYNTHES·Product code HSB·November 20, 2012

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·September 15, 2010

    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