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Nxstage Medical, Inc.

51 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (K232803)Nxstage Medical, Inc.2024-03-14
NxStage PureFlow Solution (K233213)Nxstage Medical, Inc.2024-01-18
VersiHD with GuideMe software (K230632)Nxstage Medical, Inc.2023-08-11
NxStage Cartridge Express with Speedswap (K183158)Nxstage Medical, Inc.2019-08-09
NxStage Connected Health System (K181991)Nxstage Medical, Inc.2018-09-26
NxStage System One (K171331)Nxstage Medical, Inc.2017-08-24
NxStage System One Plus (K170469)Nxstage Medical, Inc.2017-05-09
NxStage System One (K150472)Nxstage Medical, Inc.2015-06-04
NxStage Therapeutic Plasma Exchange (TPE) Cartridge (K143313)Nxstage Medical, Inc.2015-03-20
NXSTAGE SYSTEM ONE (K141752)Nxstage Medical, Inc.2014-12-19
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO (K134019)Nxstage Medical, Inc.2014-09-11
NXSTAGE EXPRESS FLUID WARMER (K140623)Nxstage Medical, Inc.2014-06-16
NXSTAGE SYSTEM ONE (K140526)Nxstage Medical, Inc.2014-05-19
NXSTAGE PUREFLOW SL (K140571)Nxstage Medical, Inc.2014-05-15
NXSTAGE SYSTEM ONE WITH NXVIEW (K133547)Nxstage Medical, Inc.2014-03-03
STREAMLINE EXPRESS (K132602)Nxstage Medical, Inc.2014-02-04
NXSTAGE 1.6M2 DIALYZER (K131050)Nxstage Medical, Inc.2013-12-27
NXSTAGE CONNECTED HEALTH SYSTEM (K131739)Nxstage Medical, Inc.2013-10-10
NXSTAGE DOSING CALCULATOR (K130460)Nxstage Medical, Inc.2013-07-11
NXSTAGE SYSTEM ONE (K122051)Nxstage Medical, Inc.2013-04-23
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS (K123395)Nxstage Medical, Inc.2013-03-07
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER (K113023)Nxstage Medical, Inc.2012-12-21
NXSTAGE PUREFLOW SL (K111174)Nxstage Medical, Inc.2011-09-19
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE (K093069)Nxstage Medical, Inc.2010-10-23
BLOOD TUBING SETS (STERILE FLUID PATH) (K090255)Nxstage Medical, Inc.2009-02-10
NXSTAGE PUREFLOW SL (K080919)Nxstage Medical, Inc.2008-10-15
BLOOD TUBING SETS (STERILE FLUID PATH) (K080807)Nxstage Medical, Inc.2008-07-18
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT (K081043)Nxstage Medical, Inc.2008-07-07
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 (K071263)Nxstage Medical, Inc.2007-08-24
NXSTAGE CARTRIDGE EXPRESS (K061837)Nxstage Medical, Inc.2006-07-31
NXSTAGE DIALYSATE PREPARATION MODULE (K060296)Nxstage Medical, Inc.2006-03-31
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION (K053286)Nxstage Medical, Inc.2005-12-22
NXSTAGE SYSTEM ONE (K050525)Nxstage Medical, Inc.2005-06-24
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS (K050727)Nxstage Medical, Inc.2005-06-13
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (K043436)Nxstage Medical, Inc.2005-03-17
NX STAGE WATER PURIFICATION SYSTEM (K042089)Nxstage Medical, Inc.2004-11-24
NXSTAGE PUREFLOW-B SOLUTION (K042045)Nxstage Medical, Inc.2004-08-27
NXSTAGE SYSTEM ONE (K041424)Nxstage Medical, Inc.2004-07-02
MODIFICATION TO NXSTAGE SYSTEM ONE (K040696)Nxstage Medical, Inc.2004-05-26
ONEVIEW INTERFACE (K040074)Nxstage Medical, Inc.2004-04-08
NXSTAGE PUREFLOW SOLUTION (K033386)Nxstage Medical, Inc.2003-11-26
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS (K032356)Nxstage Medical, Inc.2003-10-28
NXSTAGE SYSTEM ONE (K030470)Nxstage Medical, Inc.2003-07-07
NXSTAGE CARTRIDGE EXPRESS (K014152)Nxstage Medical, Inc.2002-12-11
NXSTAGE PREMIXED DIALYSATE (K022913)Nxstage Medical, Inc.2002-10-21
NXSTAGE THERAPY SYSTEM (K020858)Nxstage Medical, Inc.2002-04-17
LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR (K011269)Nxstage Medical, Inc.2002-03-04
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 (K013655)Nxstage Medical, Inc.2002-02-04
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 (K012832)Nxstage Medical, Inc.2001-10-24
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM (K012510)Nxstage Medical, Inc.2001-10-19
LIFEMATE HEMOFILTRATION SYSTEM (K001283)Nxstage Medical, Inc.2001-01-17

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