American Bentley

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
59
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K872896UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100February 12, 1988
K873923INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERNovember 6, 1987
K870804CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100September 1, 1987
K872167CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500September 1, 1987
K872133OXYGENATOR MODEL NO. BENTLEY 5 PLUSAugust 24, 1987
K870911INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALYMay 29, 1987
K870269ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100March 9, 1987
K863249OXYGENATOR MODEL NO. BENTLEY-10 PLUSOctober 20, 1986
K861641HEPARIN-COATED EXTRACORPOREAL CIRCUITSSeptember 29, 1986
K862549ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HEJuly 15, 1986
K860673OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10BJune 26, 1986
K860672ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HLMarch 3, 1986
K860106OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100February 26, 1986
K854113CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SHJanuary 8, 1986
K854045MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PEDDecember 16, 1985
K853950ARTERIAL/VENOUS SAMPLE LINE BOS-CMSLDecember 11, 1985
K853786OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100October 16, 1985
K852382CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIRSeptember 25, 1985
K852124HEMATOCRIT-SATURATION MONITOR HSM-100September 16, 1985
K841811BENTLEY-TRANTEC DISPOS. DOMES D-260-September 9, 1985