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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074033464·BONE SCREW 7042845 20 DEG ILC 8.5X45 TI

    SC5-1U Sensor Holder Package

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904090009·

    SIMPLICITY SOFT QD MICRO INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PAFLUFOCON C AND E DAILY CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 4, 2013

    SURESIGNS VS3 PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MHX·March 30, 2011

    CONTAK RENEWAL 3

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013