Baxter Healthcare Corp - FDA 510(k) Cleared Devices
505
Total
496
Cleared
0
Denied
61 devices
Cleared
Jan 09, 1992
CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS
Cardiovascular
64d
Cleared
Sep 09, 1991
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
Cardiovascular
90d
Cleared
Aug 22, 1991
MONARCH SYSTEM
Cardiovascular
167d
Cleared
Jul 22, 1991
PULSATILE ANTI-EMBOLISM SYS.PUMP
Cardiovascular
87d
Cleared
Jul 11, 1991
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
Cardiovascular
160d
Cleared
Jun 21, 1991
4.5F IMAGECATH ANGIOSCOPE
Cardiovascular
220d
Cleared
Jun 10, 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
Cardiovascular
74d
Cleared
Apr 24, 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
Cardiovascular
98d
Cleared
Apr 10, 1991
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
Cardiovascular
90d
Cleared
Apr 01, 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
Cardiovascular
75d
Cleared
Feb 07, 1991
SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER
Cardiovascular
64d
Cleared
Jan 15, 1991
SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS
Cardiovascular
85d
Cleared
Dec 17, 1990
TRANSLUMINAL ENDARTERECTOMY DEVICE
Cardiovascular
46d
Cleared
Oct 16, 1990
FOGARTY VESSEL CALIBRATOR
Cardiovascular
154d
Cleared
Sep 11, 1990
OXIMETRY PROBE CATHETERS
Cardiovascular
147d
Cleared
Jul 06, 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
Cardiovascular
88d
Cleared
Jul 03, 1990
CARDIAC OUTPUT COMPUTER, MODEL COM-3
Cardiovascular
204d
Cleared
May 10, 1990
SOFT-WEDGE(TM) SYRINGE
Cardiovascular
73d
Cleared
Mar 07, 1990
LE PTA CATHETER
Cardiovascular
259d
Cleared
Mar 06, 1990
UNIVOX-IC
Cardiovascular
190d
Cleared
Feb 08, 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
Cardiovascular
87d
Cleared
Jan 31, 1990
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
Cardiovascular
84d
Cleared
Jan 19, 1990
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
Cardiovascular
46d
Cleared
Dec 20, 1989
INFLATION PRO II
Cardiovascular
78d
Cleared
Nov 27, 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
Cardiovascular
165d