BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    XAWEX G 100

    FDA 510(k)
    FDA Class 2 ·Dental

    PYRAMESH® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000176839·LID 9050903 PYRAMESH TALL C IMPLANT LID

    Neo-Tee T-Piece Resuscitator Circuit

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043509036·

    ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TRI-FIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADAPTA

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code NVZ·April 10, 2013

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    RIATA ST OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    Baxter Interlink System Minivolume Extension Set with 0.22 Micron Filter, catalog 1C8577, Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code FPA·October 17, 2002

    Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices

    FDA Enforcement
    Class II ·Terminated·Mercury Enterprises, Inc. dba Mercury Medical·January 20, 2016

    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. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014