BEUDAMED
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    POLYSONIC ULTRASOUND LOTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ROCHESTER PEAN FORCEPS CURVED 6 1/4

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    STRATUS TDM CONTROL, LEVELS I,II,III

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·August 8, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 22, 2014

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 9, 2012

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 7, 2010

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018