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Fresenius Medical Care North America

12 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Cre recall (Z-2224-2010)Fresenius Medical Care North America2010-08-15
Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius recall (Z-2225-2010)Fresenius Medical Care North America2010-08-15
Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model recall (Z-2226-2010)Fresenius Medical Care North America2010-08-15
Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis mach recall (Z-2227-2010)Fresenius Medical Care North America2010-08-15
Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Car recall (Z-1951-2010)Fresenius Medical Care North America2010-07-01
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Prote recall (Z-0859-2009)Fresenius Medical Care North America2009-01-23
CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Prote recall (Z-0860-2009)Fresenius Medical Care North America2009-01-23
Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Ca recall (Z-0738-2008)Fresenius Medical Care North America2008-02-01
Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic recall (Z-0834-06)Fresenius Medical Care North America2006-05-03
Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux Catalog Number: 0500316N recall (Z-0333-06)Fresenius Medical Care North America2005-12-31
Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N recall (Z-0334-06)Fresenius Medical Care North America2005-12-31
Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe recall (Z-0017-05)Fresenius Medical Care North America2004-10-13

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