American Omni Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K922781FLOW CONROL VALVEMarch 8, 1993
K922356FLOW CONTROL VALVE, CAT. NO. ACV-38February 12, 1993
K900672PREBYPASS FILTER, CAT. NO. FPB-5April 3, 1990
K884893CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25January 30, 1989
K884640CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700January 24, 1989
K873316BUBBLE TRAP-FILTER CAT. NO B180F37July 14, 1988
K875080AIR VENT LINE CAT. NO. AVL-36February 29, 1988
K873802PRESSURE BARRIER KIT CAT. NO. PBK-3November 6, 1987
K873610PEDIATRIC BUBBLE TRAP CAT. NO. B-100November 5, 1987
K873488SILENT GUARD CAT. NO. SG-10October 7, 1987
K871632NASOGASTRIC VOICETUBESeptember 16, 1987
K871350PREBYPASS FILTERJune 8, 1987
K870819BUBBLE TRAP CAT. NO. B-180June 8, 1987
K864503MODIFIED RLV-2100 BJanuary 6, 1987
K862950WHITE-SIPOSS TUBE, CAT NO WS-1October 30, 1986
K861428SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100June 26, 1986
K852178EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOSDecember 27, 1985
K852407SENSOR TAPE CAT. NO. ST-45October 21, 1985
K851406AJDJUSTABLE SUCTION CONTROL VALVEAugust 5, 1985
K851465SILENT GUARD CAT. NO. SG-30August 5, 1985