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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
510(K) Number: K102726
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QUADROX-iR, used during cardiopulmonary bypass Model Item No. ... 2 05/30/2023 Maquet Medical Systems USA
QUADROX-iR, used during cardiopulmonary bypass Model Item No. ... 2 05/26/2023 Maquet Medical Systems USA
Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is... 1 03/28/2019 Maquet Cardiovascular Us Sales, Llc
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Ca... 2 05/04/2018 Maquet Cardiopulmonary Ag
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator 2 04/12/2016 Maquet Cardiovascular Us Sales, Llc
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set A... 2 05/28/2015 Maquet Cardiovascular Us Sales, Llc
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used ... 2 11/13/2014 Maquet Cardiovascular Us Sales, Llc
MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Ca... 2 10/25/2013 Maquet Medical Systems USA
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: ... 2 04/18/2013 Maquet Cardiovascular, LLC
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