Medical Device Manufacturer · US , Mchenry , IL

Baxter Healthcare Corp - FDA 510(k) Cleared Devices

505 submissions · 496 cleared · Since 1977
505
Total
496
Cleared
0
Denied
505 devices
226-250 of 505
Cleared Feb 28, 1992
FLO-GARD(R) 6201
K915522 · FRN
General Hospital · 80d
Cleared Feb 28, 1992
FLO-GARD(R) 6301
K915523 · FRN
General Hospital · 80d
Cleared Jan 09, 1992
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
K914972 · KRH
Cardiovascular · 64d
Cleared Dec 17, 1991
LAPAROLITH
K905552 · LQC
Gastroenterology & Urology · 371d
Cleared Nov 27, 1991
NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE
K914048 · FPA
General Hospital · 78d
Cleared Nov 22, 1991
LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM
K914547 · GCJ
General & Plastic Surgery · 42d
Cleared Nov 19, 1991
WALKAWAY TM 40
K911400 · LRG
Microbiology · 235d
Cleared Oct 30, 1991
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · KOC
Gastroenterology & Urology · 218d
Cleared Oct 21, 1991
FLO-GARD(R) 6200, 6300 & 8000
K913895 · FRN
General Hospital · 52d
Cleared Oct 21, 1991
8000 SERIES VOLUMETRIC PUMP SOLUTION SET
K914074 · FPA
General Hospital · 40d
Cleared Oct 17, 1991
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · JOL
General Hospital · 240d
Cleared Oct 11, 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506 · KKX
General Hospital · 65d
Cleared Sep 27, 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
K911630 · FGE
Gastroenterology & Urology · 169d
Cleared Sep 27, 1991
STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO
K912852 · JLW
Chemistry · 91d
Cleared Sep 27, 1991
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · KHO
Chemistry · 73d
Cleared Sep 25, 1991
LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE
K912839 · FBW
Gastroenterology & Urology · 91d
Cleared Sep 23, 1991
3 PORT ADAPTER
K913627 · FPA
General Hospital · 39d
Cleared Sep 11, 1991
VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE
K912141 · FPA
General Hospital · 120d
Cleared Sep 11, 1991
HYPER-K HEAT SYSTEM
K912722 · ILO
Physical Medicine · 85d
Cleared Sep 11, 1991
TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE
K913207 · KGO
General Hospital · 54d
Cleared Sep 10, 1991
HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION
K905860 · JXG
Neurology · 263d
Cleared Sep 10, 1991
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
K912679 · GJT
Hematology · 84d
Cleared Sep 09, 1991
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554 · KRH
Cardiovascular · 90d
Cleared Aug 22, 1991
MONARCH SYSTEM
K911051 · MHX
Cardiovascular · 167d
Cleared Aug 16, 1991
STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K913236 · DHA
Toxicology · 25d

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