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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 6 of 6 Results
Recall Date to: 09/21/2014 PMA Number: P950020
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Product Description
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Recall
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FDA Recall
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Recalling Firm
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Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific... 2 09/23/2006 Boston Scientific
Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Periphe... 2 09/03/2013 Boston Scientific Corporation
Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm... 2 09/03/2013 Boston Scientific Corporation
Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-... 2 12/24/2008 Boston Scientific Corporation
The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 ... 2 02/01/2006 Boston Scientific Corporation
The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical bla... 1 01/31/2006 Boston Scientific Corporation
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