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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 7 of 7 Results
510(K) Number: K082536
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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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Wire Guide, Guidewire, Global Product Number G14326 2 02/04/2020 Cook Inc.
Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-... 2 09/28/2022 Cook Incorporated
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866 2 02/04/2020 Cook Inc.
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10 2 02/04/2020 Cook Inc.
Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260 2 02/04/2020 Cook Inc.
Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285 2 02/04/2020 Cook Inc.
Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 2 02/04/2020 Cook Inc.
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