Medical Device Manufacturer · US , Eden Prairie , MN

Augustine Medical, Inc. - FDA 510(k) Cleared Devices

25 submissions · 24 cleared · Since 1987

25

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Augustine Medical, Inc. Cardiovascular ✕

13 devices

1-12 of 13

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