Baxter Healthcare Corp - FDA 510(k) Cleared Devices
Recent clearances: PrisMax System Version 2, PrisMax Control Unit, ULTRAFUSE
505
Total
496
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baxter Healthcare Corp Hematology ✕
16 devices
Cleared
Jun 26, 1996
THERMACYL BLOOD/FLUID WARMER
Hematology
321d
Cleared
Sep 10, 1991
DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
Hematology
84d
Cleared
Jun 11, 1991
DADE(R) PROTEIN C ABNORMAL CONTRAL
Hematology
43d
Cleared
Feb 26, 1991
DADE PROTEIN C CLOTTING ASSAY
Hematology
209d
Cleared
May 02, 1990
THROMBOPLASTIN.C PLUS
Hematology
42d
Cleared
Mar 06, 1990
COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN
Hematology
39d
Cleared
Apr 10, 1989
DADE THROMBOPLASTIN IS
Hematology
35d
Cleared
Feb 27, 1989
DADE(R) PLASMINOGEN CHROMOGENIC ASSAY
Hematology
34d
Cleared
Feb 02, 1989
DADE PROTEIN C CHROMOGENIC ASSAY
Hematology
72d
Cleared
Feb 02, 1989
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
Hematology
71d
Cleared
Dec 30, 1988
DADE FACTOR VIII CHROMOGENIC ASSAY
Hematology
60d
Cleared
Dec 30, 1988
DADE FACTOR IX CHROMOGENIC ASSAY
Hematology
60d
Cleared
Mar 17, 1988
IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
Hematology
16d
Cleared
Mar 16, 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
Hematology
50d
Cleared
Feb 09, 1988
CALIBRATION REFERENCE PLASMA
Hematology
69d
Cleared
Feb 04, 1988
THROMBOPLASTIN.C
Hematology
87d