| Devices | Approved 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 | |
| ARCHITECT HBsAg - P110029 | |
| Epic™ Vascular Self-Expanding Stent System - P110035 | |
| 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) | |
| 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 | |
| ARCHITECT HBsAg - P110029 | |
| Epic™ Vascular Self-Expanding Stent System - P110035 | |
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Digits of Pi
