Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

653 results for "Baxter Healthcare Corp"
97–120 of 653
Search insights Median review: 83d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 02, 2005
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
K050495 · FMF
Baxter Healthcare Corp., Bioscience
General Hospital · 63d
Cleared Nov 30, 2004
PUMP CONNECTIVITY INTERFACE
K040985 · FRN
Baxter Healthcare Corp
General Hospital · 229d
Cleared Nov 26, 2004
SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE
K042936 · FPA
Baxter Healthcare Corp
General Hospital · 32d
Cleared Oct 08, 2004
BAXJECT II
K042410 · LHI
Baxter Healthcare Corp
General Hospital · 31d
Cleared Aug 27, 2004
ACCUSOL DIALYSIS SOLUTION
K041428 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 91d
Cleared Jul 09, 2004
BAXTER INFUSOR SV (SMALL VOLUME)
K041738 · FRN
Baxter Healthcare Corporation
General Hospital · 11d
Cleared Jun 25, 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · FRN
Baxter Healthcare Corp
General Hospital · 50d
Cleared Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q,...
K031676 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 174d
Cleared Sep 05, 2003
ENDOSCOPIC APPLICATOR
K031882 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 79d
Cleared Aug 19, 2003
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · MEA
Baxter Healthcare Corp
General Hospital · 92d
Cleared Jun 17, 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
K030099 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 158d
Cleared Apr 25, 2003
EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
K030975 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Apr 25, 2003
EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
K030974 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 28d
Cleared Feb 21, 2003
SYNTRA + DIALYZER, MODEL 200
K023664 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 113d
Cleared Dec 12, 2002
AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM
K013562 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 412d
Cleared Nov 18, 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 186d
Cleared Jun 24, 2002
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · FMF
Baxter Healthcare Corp
General Hospital · 115d
Cleared Jun 07, 2002
DUPLOREACH
K014088 · FMF
Baxter Healthcare Corp
General Hospital · 177d
Cleared May 17, 2002
PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
K021274 · MEB
Baxter Healthcare Corp
General Hospital · 25d
Cleared Mar 12, 2002
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · KPE
Baxter Healthcare Corp
General Hospital · 27d
Cleared Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302,...
K012988 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 90d
Cleared Jun 28, 2001
MULTIRATE INFUSOR SV
K011317 · MEB
Baxter Healthcare Corp
General Hospital · 59d
Cleared May 15, 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · FRN
Baxter Healthcare Corp
General Hospital · 78d
Cleared Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747 · DBA
Baxter Healthcare Corp
Immunology · 105d