Augustine Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM, MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX, AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
25
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - Augustine Medical, Inc. Cardiovascular ✕
13 devices
Cleared
Jul 09, 2002
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
Cardiovascular
62d
Cleared
Sep 06, 2000
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT...
Cardiovascular
149d
Cleared
Jun 26, 1997
BAIR HUGGER MODEL 630 CARDIAC BLANKET
Cardiovascular
217d
Cleared
Jan 06, 1997
MODEL 90022 ROLLING STAND
Cardiovascular
115d
Cleared
Jun 17, 1996
SYSTEM, THERMAL REGULATING 74-DWJ
Cardiovascular
153d
Cleared
Sep 12, 1995
BAIR HUGGER MODEL 655 BLANKET
Cardiovascular
82d
Cleared
Aug 29, 1995
BAIR HUGGER MODEL 600 UNIT, BLANKETS
Cardiovascular
210d
Cleared
Aug 06, 1992
BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540
Cardiovascular
148d
Cleared
Jun 18, 1992
BAIR HUGGER CUB BLANKET- SHORT MODEL 536
Cardiovascular
136d
Cleared
Mar 27, 1992
BAIR HUGGER PATIENT WARMING SYSTEM
Cardiovascular
66d
Cleared
Oct 23, 1991
BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER
Cardiovascular
64d
Cleared
Aug 14, 1990
BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION
Cardiovascular
29d