BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    BIPOLAR HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Millenium HX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HSV STRAW

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·June 24, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 3, 2010

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·November 30, 2012

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015