Shiley, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
174
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K920594SHILEY PERFUSION TUBING SETSMarch 18, 1993
K910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMNovember 27, 1991
K911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200August 9, 1991
K910923BCD ADVANCEDApril 9, 1991
K901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASJanuary 14, 1991
K903435SHILEY SPECIALIZED TRACHEOSTOMY TUBEOctober 2, 1990
K901624SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.July 3, 1990
K901249PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATORJune 11, 1990
K901250PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATORJune 11, 1990
K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRMay 10, 1990
K900548SHILEY PHONATION VALVEApril 23, 1990
K900753SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)April 10, 1990
K900186BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SETApril 10, 1990
K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESMarch 28, 1990
K894784MODIFIED SHILEY FEMORAL VENOUS CANNULAMarch 28, 1990
K893711DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIRFebruary 28, 1990
K895149NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SYNovember 28, 1989
K895150CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORINGNovember 28, 1989
K895388SHILEY ELBOW 15MM SWIVEL CONNECTOROctober 27, 1989
K894630SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOROctober 20, 1989