BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    BIOTIS MARTIN LEWIS AGAR

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DISPOSABLE, HYPERBARIC OXYGEN CHAMBER

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

    Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 2, 2014

    6 SHOOTER SAEED MULTI BAND LIGATOR

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code MND·October 25, 2012

    FINESSE PATCH

    FDA Adverse Event
    Malfunction ·CALIBRA MEDICAL, INC·Product code LZG·June 15, 2015

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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