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Terumo Cardiovascular Corporation

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 recall (Z-0842-2012)Terumo Cardiovascular Corporation2012-01-24
CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, use recall (Z-2950-2011)Terumo Cardiovascular Corporation2011-08-04
Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375 recall (Z-2610-2010)Terumo Cardiovascular Corporation2010-09-29
Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720 recall (Z-2611-2010)Terumo Cardiovascular Corporation2010-09-29
Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501 recall (Z-2612-2010)Terumo Cardiovascular Corporation2010-09-29
Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010 recall (Z-2613-2010)Terumo Cardiovascular Corporation2010-09-29
Cardiovascular Procedure Kit X-Coated Pump and Table Pack, Item #71552 recall (Z-2614-2010)Terumo Cardiovascular Corporation2010-09-29
Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ recall (Z-2615-2010)Terumo Cardiovascular Corporation2010-09-29
Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), recall (Z-2616-2010)Terumo Cardiovascular Corporation2010-09-29
Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03 recall (Z-2617-2010)Terumo Cardiovascular Corporation2010-09-29
Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Proce recall (Z-2606-2010)Terumo Cardiovascular Corporation2010-09-28

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Every clearance here is in the API, with alerts when new ones post.