Augustine Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
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
Cleared
Jul 09, 2002
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
Cardiovascular
62d
Cleared
Jan 31, 2002
MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
General & Plastic Surgery
22d
Cleared
Sep 06, 2000
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT...
Cardiovascular
149d
Cleared
Apr 30, 1998
BAIR HUGGER BLOOD/FLUID WARMER
Hematology
211d
Cleared
Jun 26, 1997
BAIR HUGGER MODEL 630 CARDIAC BLANKET
Cardiovascular
217d
Cleared
Mar 28, 1997
AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
General & Plastic Surgery
219d
Cleared
Jan 06, 1997
MODEL 90022 ROLLING STAND
Cardiovascular
115d
Cleared
Jun 17, 1996
SYSTEM, THERMAL REGULATING 74-DWJ
Cardiovascular
153d
Cleared
Dec 29, 1995
AUGUSTINE INTUBATION GUIDE
Anesthesiology
95d
Cleared
Sep 12, 1995
BAIR HUGGER MODEL 655 BLANKET
Cardiovascular
82d
Cleared
Aug 29, 1995
BAIR HUGGER MODEL 600 UNIT, BLANKETS
Cardiovascular
210d
Cleared
Jan 28, 1994
MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
General Hospital
179d