BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    LUMENVU CATHETER GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198291·AK3 PS Insert Trial Size 5, 10mm

    POINT 4 MODIFIED

    FDA 510(k)
    FDA Class 2 ·Dental

    INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

    FDA 510(k)
    FDA Class 2 ·Radiology

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·May 6, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 16, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CTR - SILICON VALLEY·Product code GEX·April 6, 2011

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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