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Augustine Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K021473BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMJuly 9, 2002
K020077MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXXJanuary 31, 2002
K001149AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNITSeptember 6, 2000
K973741BAIR HUGGER BLOOD/FLUID WARMERApril 30, 1998
K964673BAIR HUGGER MODEL 630 CARDIAC BLANKETJune 26, 1997
K963293AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXXMarch 28, 1997
K963672MODEL 90022 ROLLING STANDJanuary 6, 1997
K960167SYSTEM, THERMAL REGULATING 74-DWJJune 17, 1996
K954446AUGUSTINE INTUBATION GUIDEDecember 29, 1995
K952864BAIR HUGGER MODEL 655 BLANKETSeptember 12, 1995
K950416BAIR HUGGER MODEL 600 UNIT, BLANKETSAugust 29, 1995
K933726MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEMJanuary 28, 1994
K921165BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540August 6, 1992
K920432BAIR HUGGER CUB BLANKET- SHORT MODEL 536June 18, 1992
K915161AUGUSTINE FIBEROPTIC LARYNGOSCOPEMay 29, 1992
K921166AUGUSTINE GUIDE KITApril 23, 1992
K920468AUGUSTINE STYLETApril 23, 1992
K920265BAIR HUGGER PATIENT WARMING SYSTEMMarch 27, 1992
K913734BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVEROctober 23, 1991
K914168AUGUSTINE GUIDE KIT WITH GAUZE SPONGEOctober 7, 1991