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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 5 of 5 Results
510(K) Number: K092575
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Product Description
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Recall
Class
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FDA Recall
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Recalling Firm
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St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D.,... 1 08/12/2010 St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D.... 1 08/12/2010 St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D... 1 08/12/2010 St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D.... 1 08/12/2010 St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D.... 1 08/12/2010 St. Jude Medical Cardiovascular Division
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