BEUDAMED
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    SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9652360·

    IRIS G-PROBE

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

    IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADAPTA

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVZ·February 15, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LGW·July 29, 2014

    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·August 31, 2016