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

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    GORE TRI-LOBE BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE® TRI-LOBE BALLOON CATHETER

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 2021

    SEE H10

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011

    EVERSTICKNET

    FDA 510(k)
    FDA Class 2 ·Dental

    DC-TELL

    FDA 510(k)
    FDA Class 2 ·Dental

    SYRINGE ENTERAL 50ML BNS

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·June 16, 2020

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    BARD

    FDA Adverse Event
    Death ·BARD MEDICAL DIV.·Product code DTK·May 3, 2011

    CYLOS DR-T

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DXY·July 23, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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