| Submission Date | Company Name | Ticker | Device | Category | Outcome | Details |
| 04/10/2012 | Tangent Medical (Private) | | NovaCath Secure IV Catheter System to address several complex IV therapy challenges | 510(k) |
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| 01/24/2012 | InSightec Ltd (Private) | | ExAblate for treatment of painful bone metastases | PMA |
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| 01/09/2012 | Cameron Health Inc. (Private) | | S-ICD System, a subcutaneous implantable defibrillator | PMA |
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| 01/09/2012 | Cameron Health, Inc (Private) | | S-ICD System for patients at risk of sudden cardiac arrest | PMA |
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| 01/05/2012 | LipoScience Inc. (Private) | | Vantera Clinical Analyzer for in vitro diagnostic use | 510 (k) |
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| 12/21/2011 | GenMark Diagnostics, Inc. | GNMK | eSensor Respiratory Viral Panel to identify multiple viruses | 510 (k) |
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| 11/14/2011 | Great Basin Corp. (Private) | | Molecular diagnostic test for Clostridium difficile | 510 (k) |
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| 10/13/2011 | Freedom Meditech Inc. (Private) | | ClearPath DS-120 Lens Fluorescence Biomicroscope to detect chronic eye disease | 510(k) |
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| 09/01/2011 | Cytomedix Inc | CYME.OB, GTF | Angel Whole Blood Separation System for processing bone marrow aspirate | 510 (k) |
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| 08/11/2011 | Nephros Inc. | NEPH.OB | Hemodiafiltration system for end-stage renal disease | 510 (k) |
FDA requested addnl info on Nov.8, 2011
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| 08/05/2011 | Qiagen NV | QGEN, QGENF | KRAS RGQ PCR Kit for use as a companion diagnostic with metastatic colorectal cancer drug Erbitux | PMA |
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| 07/26/2011 | Roche Holding AG | RHHBY.PK | Elecsys Anti-HBc IgM assay (hepatitis B test) | PMA |
Approved on Oct.31, 2011
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| 07/11/2011 | PositiveID Corp. | PSID | iglucose mobile health system for diabetes management | 510(k) |
Cleared on Nov.17, 2011
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| 05/20/2011 | Gen-Probe Inc. | GPRO | PANTHER system , a fully automated integrated molecular testing instrument | 510 (k) |
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| 04/11/2011 | HANSEN MEDICAL INC | HNSN | Vascular Robotic System and Catheter. | 510 (k) |
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