BEUDAMED
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    Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Symetri Clear

    FDA UDI
    ORMCO CORPORATION·00889989084726·L5L SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI...

    FACIAL SPA

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    UNICEL® DXC 600I SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 28, 2011

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

    MITEK RIGIDFIX 3.3 ST CROSS PIN KIT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MAI·September 25, 2008

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GGK·June 23, 2009

    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