2011 Devices: Approved or Recalled?

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Can you name the 2011 Devices: Approved or Recalled??

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DevicesApproved or Recalled in 2012?
Roche Diagnostics Operations, Inc.: Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays
Thoratec Corporation: HeartMate II Left Ventricular Assist System (LVAS)
Presillion plus CoCr Coronary Stent on RX System - P110004
Absolute Pro® Vascular Self-Expanding Stent System - P110028
Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.
Prometra® Programmable Infusion Pump System - P080012
Respironics, Inc: Trilogy 100 Ventilators
Breast Companion® Software System - P100007
M-Vu Algorithm Engine - P100005
Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)
DevicesApproved or Recalled in 2012?
Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy
Sientra Silicone Gel Breast Implants - P070004
LINX™ Reflux Management System - P100049
Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator
Smiths Medical Bivona Neonatal, Pediatric and Flextend Tracheostomy Tubes
PROGENSA® PCA3 Assay - P100033
CareFusion NicoletOne Software Used with CareFusion Cortical Stimulator Control Unit
Epic™ Vascular Self-Expanding Stent System - P110035

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