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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 3 of 3 Results
510(K) Number: K981909
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Product Description
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FDA Recall
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Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LL... 2 07/11/2011 Edwards Lifesciences, LLC
Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port A... 2 07/11/2011 Edwards Lifesciences, LLC
Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated... 2 08/25/2009 Edwards Lifesciences, Llc
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