BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    PLASMAJET SYSTEM

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

    Hern Dilator

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030819·Hern Dilator 77Fr (25.6 mm)

    Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

    FDA UDI
    TENON MEDICAL, INC.·B74240308190·10mm Drill Guide

    HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PHILIPS CT SECURA MV

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·March 27, 2013

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DWC·March 4, 2011

    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·April 17, 2008

    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