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

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    ODYSSEY WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065807·EXTRAORAL ELASTIC KIT

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450456828·

    MODIFICATION TO VNUS CLOSURE SYSTEM

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

    HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 21, 2015

    VELA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·February 19, 2015

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTP·September 16, 2014

    1.9FX50CM VASCU-PICC

    FDA Adverse Event
    Malfunction ·MEDCOMP·Product code LJS·April 15, 2011

    2008T HEMODIALYSIS SYS., WITH CDX

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KDI·June 26, 2018

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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