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Baxter Healthcare Corp.: 510(k) Clearances

570 510(k) clearances from Jan 6, 1977 to Dec 16, 2025, newest first. Showing 101 to 200.

What this list covers: FDA records filed under the name "Baxter Healthcare Corp." and its spelling variants "Baxter Healthcare", "Baxter Healthcare Corporation", "Baxter Corporation", "Baxter".

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K-NumberDeviceDate
K030099BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000Jun 17, 2003
K030975EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210Apr 25, 2003
K030974EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170Apr 25, 2003
K023664SYNTRA + DIALYZER, MODEL 200Feb 21, 2003
K013562AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH…Dec 12, 2002
K021615BAXTER ACCURA SYSTEM, MODEL 5M5660Nov 18, 2002
K020666DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5MLJun 24, 2002
K014088DUPLOREACHJun 7, 2002
K021274PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719May 17, 2002
K020485ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 MLMar 12, 2002
K012988HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469Dec 5, 2001
K011317MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEMJun 28, 2001
K010566COLLEAGUE VOLUMETRIC INFUSION PUMPMay 15, 2001
K003747C1-INHIBITOR MICROTITER ASSAY DEVICEMar 19, 2001
K002210SYNTRA DIALYZER, MODEL SYNTRA 120, 160Feb 14, 2001
K003730CHEMO-AIDE DISPENSING PINDec 20, 2000
K003616COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMPDec 12, 2000
K003245HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/MLDec 4, 2000
K001685PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210Nov 15, 2000
K003193DUPLOGRIPNov 7, 2000
K003225SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVEOct 19, 2000
K000664VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORSSep 20, 2000
K0026796060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351Sep 18, 2000
K002739INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067KSep 11, 2000
K002380INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEMSep 5, 2000
K002211COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151Jul 28, 2000
K001063SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7Jul 7, 2000
K981089TISSOMAT AND SPRAY SETJul 5, 2000
K992532VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATINGJun 13, 2000
K001422PSN HEMODIALYZER, MODELS PSN 170, PSN 210Jun 2, 2000
K000657LUER ACCESS UNIVERSAL VIAL ADAPTERMar 8, 2000
K992894MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576Nov 24, 1999
K993120MODIFIED BLOOD RECIPIENT SETNov 17, 1999
K993387IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107KNov 1, 1999
K9845900.9% SODIUM CHLORIDE FLUSH SYRINGEOct 7, 1999
K984060LUER ACCESS INJECTION SITEJul 26, 1999
K990953RENAL LINKJun 18, 1999
K984381BURETROL SOLUTION SETSFeb 19, 1999
K983294ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122…Nov 3, 1998
K982822FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION…Sep 30, 1998
K982672COLLEAGUE PUMP SYRINGE ADAPTER SETSep 4, 1998
K982102SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC…Sep 4, 1998
K981792SOLUTION ADMINISTRATION SETAug 17, 1998
K974652BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLERJul 10, 1998
K974571SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVEMay 21, 1998
K980658PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234May 19, 1998
K980656PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236May 19, 1998
K981318DUAL LUER LOCK CAPApr 22, 1998
K970662CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)Mar 11, 1998
K970653CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Mar 11, 1998
K974397STERILE SALINE FOR CATHETER CAREFeb 10, 1998
K974155BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO…Jan 22, 1998
K970663CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)Jan 11, 1998
K963933PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZERNov 24, 1997
K970661CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)Nov 12, 1997
K970654CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Nov 12, 1997
K973654VIAL-MATE RECONSTITUTION DEVICE (2B8071)Oct 24, 1997
K961008AUTOMIX 3+3/AS COMPOUNDER SYSTEMOct 10, 1997
K972579HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH…Oct 1, 1997
K970591BLOOD MONITOR PUMPSep 9, 1997
K972159FENWAL 40 MICRON TRANSFUSION FILTERJul 23, 1997
K971168ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATEJul 15, 1997
K971701CONTINU-FLO SOLUTION SETJun 6, 1997
K955816VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITORMay 6, 1997
K955622AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;May 6, 1997
K970438INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETSApr 2, 1997
K964853INTRAVIA CONTAINER, EMPTYMar 31, 1997
K963203BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENTMar 25, 1997
K964029EMERGENCY RELIEF KIT SYSTEMMar 17, 1997
K964850SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTERFeb 25, 1997
K961341CONVERTORS POLYOLEFIN FABRIC GOWNSOct 28, 1996
K962907SKINNY,FRANSEEN,WESCOTT NEEDLESOct 23, 1996
K962893INTERLINK ADAPTER FOR CONVENTIONAL Y-SITEOct 18, 1996
K963390BIOPSY INTRODUCER NEEDLEOct 10, 1996
K962581STOPCOCK MANIFOLD GANGSAug 28, 1996
K962161BAXTER NEBULIZER CAP MODEL 2D0868Aug 15, 1996
K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493Aug 6, 1996
K962022POWERCUT GOLD SURGICAL SYSTEMAug 5, 1996
K961703COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE…Jul 8, 1996
K961495HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK…Jun 26, 1996
K953741THERMACYL BLOOD/FLUID WARMERJun 26, 1996
K961225CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SETJun 21, 1996
K961154BAXTER SODIUM ACETATE INFANT HEEL WARMERJun 6, 1996
K960955JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATINGMay 22, 1996
K960787TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSMay 14, 1996
K952879SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENTApr 22, 1996
K96050918 GAUGE TRU-CUT BIOPSY NEEDLEApr 4, 1996
K955277ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSISFeb 16, 1996
K954529AUTOMATED TRU-CUT BIOPSY DEVICEDec 29, 1995
K953098VOLUMETRIC INFUSION PUMPDec 22, 1995
K951566SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC…Nov 27, 1995
K954218STERILE FEEDING TUBENov 3, 1995
K951247SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORSNov 2, 1995
K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLESep 22, 1995
K950680INFANT HEEL WARMERAug 23, 1995
K951413FOGARTY-HYDRAGRIP SURGICAL CLAMPSAug 18, 1995
K951949CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.Aug 11, 1995
K951529V. MUELLER OBSTETRICAL (OB) FORCEPSAug 4, 1995
K952074SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTERJul 27, 1995
K952786TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVESJul 20, 1995

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.