BEUDAMED
    11 results · 34ms · Sources: EU EUDAMED, US FDA

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    CK-MB(IMMUNOLOGICAL)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707008194·STRAIGHT WIRES SPRING HARD 21x25

    ACUMED

    FDA UDI
    Acumed LLC·10806378105227·FFN 2 Base Set Case Base

    FacetLINK MI

    FDA UDI
    LINKSPINE, INC.·00817329024606·Facet Screw Driver Outer Tube

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPARTAN MTS

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·May 9, 2014

    AXIUM

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code HCG·September 17, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·May 26, 2015

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012