BEUDAMED
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    PULPDENT DESENSITIZER

    FDA 510(k)
    FDA Class 2 ·Dental

    Sklar

    FDA UDI
    SKLAR CORPORATION·50649111456549·COLIBRI FCP NOTCHED 4 IN CS/10

    GLOBAL AP POROUS COATED HUMERAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ePlex Instrument

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·February 15, 2013

    COOL FLEX CATH, 1304-CF-7-0.5(5)5-L-TE4BE1EB

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, IRVINE·Product code OAD·December 21, 2010

    2008K HEMODIALYSIS SYS. OLC.DIASAFE PLUS

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·May 22, 2014

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 2015