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

Augustine Medical, Inc. has 24 FDA 510(k) cleared medical devices. Based in Eden Prairie, US.

Historical record: 24 cleared submissions from 1987 to 2002. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Augustine Medical, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Augustine Medical, Inc.
25 devices
1-25 of 25
Cleared Jul 09, 2002
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K021473 · DWJ
Cardiovascular · 62d
Cleared Jan 31, 2002
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
K020077 · MSA
General & Plastic Surgery · 22d
Cleared Sep 06, 2000
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT...
K001149 · DWJ
Cardiovascular · 149d
Cleared Apr 30, 1998
BAIR HUGGER BLOOD/FLUID WARMER
K973741 · BSB
Hematology · 211d
Cleared Jun 26, 1997
BAIR HUGGER MODEL 630 CARDIAC BLANKET
K964673 · DWJ
Cardiovascular · 217d
Cleared Mar 28, 1997
AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
K963293 · MSA
General & Plastic Surgery · 219d
Cleared Jan 06, 1997
MODEL 90022 ROLLING STAND
K963672 · JOW
Cardiovascular · 115d
Cleared Jun 17, 1996
SYSTEM, THERMAL REGULATING 74-DWJ
K960167 · DWJ
Cardiovascular · 153d
Cleared Dec 29, 1995
AUGUSTINE INTUBATION GUIDE
K954446 · CCW
Anesthesiology · 95d
Cleared Sep 12, 1995
BAIR HUGGER MODEL 655 BLANKET
K952864 · DWJ
Cardiovascular · 82d
Cleared Aug 29, 1995
BAIR HUGGER MODEL 600 UNIT, BLANKETS
K950416 · DWJ
Cardiovascular · 210d
Cleared Jan 28, 1994
MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
K933726 · LHC
General Hospital · 179d
Cleared Aug 06, 1992
BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540
K921165 · DWJ
Cardiovascular · 148d
Cleared Jun 18, 1992
BAIR HUGGER CUB BLANKET- SHORT MODEL 536
K920432 · DWJ
Cardiovascular · 136d
Cleared May 29, 1992
AUGUSTINE FIBEROPTIC LARYNGOSCOPE
K915161 · CCW
Anesthesiology · 197d
Cleared Apr 23, 1992
AUGUSTINE STYLET
K920468 · BSR
Anesthesiology · 87d
Cleared Apr 23, 1992
AUGUSTINE GUIDE KIT
K921166 · CCW
Anesthesiology · 43d
Cleared Mar 27, 1992
BAIR HUGGER PATIENT WARMING SYSTEM
K920265 · DWJ
Cardiovascular · 66d
Cleared Oct 23, 1991
BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER
K913734 · DWJ
Cardiovascular · 64d
Cleared Oct 07, 1991
AUGUSTINE GUIDE KIT WITH GAUZE SPONGE
K914168 · CCW
Anesthesiology · 20d
Cleared Sep 04, 1991
AUGUSTINE GUIDE(TM) KIT
K912690 · BSR
Anesthesiology · 78d
Cleared May 17, 1991
AUGUSTINE STYLET
K910659 · BSR
Anesthesiology · 92d
Cleared Aug 14, 1990
BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION
K903360 · DWJ
Cardiovascular · 29d
Cleared Jul 21, 1988
AUGUSTINE INTUBATION GUIDE(TM)
K882659 · CCW
Anesthesiology · 23d
Cleared Nov 06, 1987
BAIR HUGGER(TM) - PATIENT WARMING SYSTEM
K873745 · DWJ
Cardiovascular · 51d
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