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NxStage Medical Inc

17 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, recall (Z-1864-2025)NxStage Medical Inc2025-05-28
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers R recall (Z-2160-2024)NxStage Medical Inc2024-06-20
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactat recall (Z-1854-2014)NxStage Medical, Inc.2014-06-24
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactat recall (Z-1855-2014)NxStage Medical, Inc.2014-06-24
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactat recall (Z-1856-2014)NxStage Medical, Inc.2014-06-24
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactat recall (Z-1857-2014)NxStage Medical, Inc.2014-06-24
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactat recall (Z-1858-2014)NxStage Medical, Inc.2014-06-24
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactat recall (Z-1859-2014)NxStage Medical, Inc.2014-06-24
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactat recall (Z-1860-2014)NxStage Medical, Inc.2014-06-24
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactat recall (Z-1861-2014)NxStage Medical, Inc.2014-06-24
NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case recall (Z-1073-2014)NxStage Medical, Inc.2014-02-24
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage recall (Z-1214-2013)NxStage Medical, Inc.2013-05-02
NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFl recall (Z-0826-2012)NxStage Medical, Inc.2012-01-20
NxStage Cartridge Express, CAR-170, for hemodialysis. recall (Z-1228-2007)NxStage Medical, Inc.2007-09-20
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo recall (Z-1069-04)NxStage Medical, Inc.2004-07-20
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo recall (Z-1070-04)NxStage Medical, Inc.2004-07-20
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo recall (Z-1071-04)NxStage Medical, Inc.2004-07-20

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