American Omni Medical, Inc. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
16 devices
Cleared
Mar 08, 1993
FLOW CONROL VALVE
Cardiovascular
272d
Cleared
Feb 12, 1993
FLOW CONTROL VALVE, CAT. NO. ACV-38
Cardiovascular
269d
Cleared
Apr 03, 1990
PREBYPASS FILTER, CAT. NO. FPB-5
Cardiovascular
49d
Cleared
Jan 30, 1989
CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
Cardiovascular
69d
Cleared
Jan 24, 1989
CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
Cardiovascular
78d
Cleared
Jul 14, 1988
BUBBLE TRAP-FILTER CAT. NO B180F37
Cardiovascular
330d
Cleared
Feb 29, 1988
AIR VENT LINE CAT. NO. AVL-36
Cardiovascular
82d
Cleared
Nov 06, 1987
PRESSURE BARRIER KIT CAT. NO. PBK-3
Cardiovascular
49d
Cleared
Oct 07, 1987
SILENT GUARD CAT. NO. SG-10
Cardiovascular
37d
Cleared
Jun 08, 1987
BUBBLE TRAP CAT. NO. B-180
Cardiovascular
97d
Cleared
Jun 08, 1987
PREBYPASS FILTER
Cardiovascular
63d
Cleared
Jan 06, 1987
MODIFIED RLV-2100 B
Cardiovascular
53d
Cleared
Jun 26, 1986
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100
Cardiovascular
71d
Cleared
Oct 21, 1985
SENSOR TAPE CAT. NO. ST-45
Cardiovascular
137d
Cleared
Aug 05, 1985
AJDJUSTABLE SUCTION CONTROL VALVE
Cardiovascular
118d
Cleared
Aug 05, 1985
SILENT GUARD CAT. NO. SG-30
Cardiovascular
116d