BEUDAMED
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    AVL OPTI CRITICAL CARE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984299·anteriors; shade B2; mould R 89

    APA-C CATALOG NUMBER A-8001-C

    FDA 510(k)
    FDA Class 2 ·Radiology

    REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013

    RENAL - DISPOSABLE

    FDA Adverse Event
    Death ·Product code KDJ·February 10, 2011

    AL-III W/FOOT CONTROL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·December 18, 2013

    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

    InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.

    FDA Recall
    Terminated ·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009

    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