Medical Device Manufacturer · US , Eden Prairie , MN

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

25 submissions · 24 cleared · Since 1987

Total

Cleared

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

1-12 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

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

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