Augustine Medical, Inc.
Eden Prairie, MN, US
Augustine Medical, Inc. appears in FDA device records in Eden Prairie, MN. FDA records list 25 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 25
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 25 510(k) clearances for Augustine Medical, Inc. between 1987 and 2002. The busiest year on record is 1992, with 6. The most recent is 2002, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1988 | 1 |
| 1990 | 1 |
| 1991 | 4 |
| 1992 | 6 |
| 1994 | 1 |
| 1995 | 3 |
| 1996 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 2000 | 1 |
| 2002 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K021473 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM | DWJ | Substantially Equivalent | |
| K020077 | MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX | MSA | Substantially Equivalent | |
| K001149 | AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK | DWJ | Substantially Equivalent | |
| K973741 | BAIR HUGGER BLOOD/FLUID WARMER | BSB | Substantially Equivalent | |
| K964673 | BAIR HUGGER MODEL 630 CARDIAC BLANKET | DWJ | Substantially Equivalent | |
| K963293 | AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX | MSA | Substantially Equivalent for Some Indications | |
| K963672 | MODEL 90022 ROLLING STAND | JOW | Substantially Equivalent | |
| K960167 | SYSTEM, THERMAL REGULATING 74-DWJ | DWJ | Substantially Equivalent | |
| K954446 | AUGUSTINE INTUBATION GUIDE | CCW | Substantially Equivalent | |
| K952864 | BAIR HUGGER MODEL 655 BLANKET | DWJ | Substantially Equivalent | |
| K950416 | BAIR HUGGER MODEL 600 UNIT, BLANKETS | DWJ | Substantially Equivalent | |
| K933726 | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM | LHC | Substantially Equivalent | |
| K921165 | BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 | DWJ | Substantially Equivalent | |
| K920432 | BAIR HUGGER CUB BLANKET- SHORT MODEL 536 | DWJ | Substantially Equivalent | |
| K915161 | AUGUSTINE FIBEROPTIC LARYNGOSCOPE | CCW | Substantially Equivalent | |
| K921166 | AUGUSTINE GUIDE KIT | CCW | Substantially Equivalent | |
| K920468 | AUGUSTINE STYLET | BSR | Substantially Equivalent | |
| K920265 | BAIR HUGGER PATIENT WARMING SYSTEM | DWJ | Substantially Equivalent | |
| K913734 | BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER | DWJ | Substantially Equivalent | |
| K914168 | AUGUSTINE GUIDE KIT WITH GAUZE SPONGE | CCW | Substantially Equivalent | |
| K912690 | AUGUSTINE GUIDE(TM) KIT | BSR | Substantially Equivalent | |
| K910659 | AUGUSTINE STYLET | BSR | Substantially Equivalent | |
| K903360 | BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION | DWJ | Substantially Equivalent | |
| K882659 | AUGUSTINE INTUBATION GUIDE(TM) | CCW | Substantially Equivalent | |
| K873745 | BAIR HUGGER(TM) - PATIENT WARMING SYSTEM | DWJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain