Panels › Cardiovascular › Product code DWJ · Class 2
System, Thermal Regulating
Regulation 870.5900
5510(k)s in 12 months (161 all time)
3recalls in 12 months (70 all time)
58recalls that name a 510(k)
Top companies in DWJ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 13, 2000 | K003349 | ALLON 2001 MODIFIED Mtre Advanced Technology , Ltd. | DWJ |
| Oct 26, 2000 | K002577 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS Medivance, Inc. | DWJ |
| Sep 6, 2000 | K001149 | AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK Augustine Medical, Inc. | DWJ |
| Jun 8, 2000 | K001546 | ALLON 2001 Mtre Advanced Technology , Ltd. | DWJ |
| Mar 28, 2000 | K981093 | WESCO BLANKET Wesco, Inc. | DWJ |
| Mar 7, 2000 | K992386 | ALLON 2000 Mtre Advanced Technology , Ltd., IL | DWJ |
| Mar 1, 2000 | K991684 | CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001 Thermogear, Inc. | DWJ |
| Aug 7, 1998 | K973705 | CONTOR TABLE SURFACE Hill-Rom, Inc. | DWJ |
| Dec 17, 1997 | K970367 | THERMO-STAT SYSTEM Aquarius Medical Corp. | DWJ |
| Jun 26, 1997 | K964673 | BAIR HUGGER MODEL 630 CARDIAC BLANKET Augustine Medical, Inc. | DWJ |
| Apr 23, 1997 | K964377 | THERMAL REGULATION SYSTEM BLANKET Gibeck, Inc. | DWJ |
| Apr 22, 1997 | K963731 | TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT Enthermics Medical Systems, Inc. | DWJ |
| Jan 13, 1997 | K960511 | GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET Gibeck, Inc. | DWJ |
| Jun 17, 1996 | K960167 | SYSTEM, THERMAL REGULATING 74-DWJ Augustine Medical, Inc. | DWJ |
| Jan 17, 1996 | K952329 | LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM Progressive Dynamics, Inc. | DWJ |
| Sep 12, 1995 | K952864 | BAIR HUGGER MODEL 655 BLANKET Augustine Medical, Inc. | DWJ |
| Sep 6, 1995 | K952086 | TROPICAIR CONVECTIVE WARMING BLANKETS Seabrook Medical Systems, Inc. | DWJ |
| Sep 6, 1995 | K946196 | TROPICAIR CONVECTIVE WARING SYSTEM Seabrook Medical Systems, Inc. | DWJ |
| Aug 29, 1995 | K950416 | BAIR HUGGER MODEL 600 UNIT, BLANKETS Augustine Medical, Inc. | DWJ |
| May 23, 1995 | K942881 | TC 3000 Gaymar Industries, Inc. | DWJ |
| Jan 24, 1995 | K942790 | WARM AIR HYPERTHEERMIA SYSTEM (MODELS #130 AND #133) Cincinnati Sub-Zero Products, Inc. | DWJ |
| Jan 24, 1995 | K942599 | WARM AIR WARMING UNIT Cincinnati Sub-Zero Products, Inc. | DWJ |
| Sep 19, 1994 | K943276 | WARMTOUCH PLASTIC WARMING COVER Mallinckrodt Medical | DWJ |
| Mar 9, 1994 | K940171 | CABOT MEDICAL NIAGRA-TRS THERMAL RETENTION SYSTEM Cabot Medical Corp. | DWJ |
| Nov 9, 1993 | K933764 | LIFE-AIR 1000 PATIENT WARMING COVER Progressive Dynamics, Inc. | DWJ |
| Aug 6, 1993 | K930345 | TC2000 POWER UNIT AND ACCESSORIES Gaymar Industries, Inc. | DWJ |
| Jul 13, 1993 | K923104 | TROPIC-AIR Seabrook Medical Systems, Inc. | DWJ |
| Dec 11, 1992 | K921920 | SOFT-TEMP Adroit Medical Systems, Inc. | DWJ |
| Aug 6, 1992 | K921165 | BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540 Augustine Medical, Inc. | DWJ |
| Jun 18, 1992 | K920432 | BAIR HUGGER CUB BLANKET- SHORT MODEL 536 Augustine Medical, Inc. | DWJ |
| Apr 21, 1992 | K914382 | LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM Progressive Dynamics, Inc. | DWJ |
| Mar 30, 1992 | K914383 | LIFE-AIR 1000 PATIENT WARMING COVERS Progressive Dynamics, Inc. | DWJ |
| Mar 27, 1992 | K920265 | BAIR HUGGER PATIENT WARMING SYSTEM Augustine Medical, Inc. | DWJ |
| Jan 7, 1992 | K914805 | TC-1000, TC-1050 SYSTEM Gaymar Industries, Inc. | DWJ |
| Oct 23, 1991 | K913734 | BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER Augustine Medical, Inc. | DWJ |
| Sep 4, 1991 | K913016 | WARMTOUCH Advanced Warming Systems, Inc. | DWJ |
| Jul 30, 1991 | K912051 | MEDI-THERM (MTA-5900) & DETACHABLE HOSES Gaymar Industries, Inc. | DWJ |
| May 16, 1991 | K910327 | WARMAIR SYSTEM Cincinnati Sub-Zero Products, Inc. | DWJ |
| Feb 1, 1991 | K904690 | TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM Marquest Medical Products, Inc. | DWJ |
| Dec 20, 1990 | K902650 | BODYHEAT Medadvances, Inc. | DWJ |
| Oct 22, 1990 | K902756 | TROPI-COOL Seabrook Medical Systems, Inc. | DWJ |
| Aug 14, 1990 | K903360 | BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION Augustine Medical, Inc. | DWJ |
| Apr 10, 1990 | K900186 | BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET Shiley, Inc. | DWJ |
| Nov 2, 1989 | K894980 | BIO-CAL 370 HEATER/COOLER Bio Medicus, Inc. | DWJ |
| May 5, 1989 | K890575 | ACCUTHERM PTS-200 Medical Repackers Co. | DWJ |
| Sep 6, 1988 | K882442 | RK2000 K-THERMIA SYSTEM Baxter Healthcare Corp | DWJ |
| Jul 28, 1988 | K882035 | HEART-CHILL SALINE SLUSH PAD Buckman Co., Inc. | DWJ |
| Jun 22, 1988 | K881322 | MINI-TEMP(TM) Seabrook Medical Systems, Inc. | DWJ |
| Jan 29, 1988 | K873546 | VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM Reimers Engineering, Inc. | DWJ |
| Nov 6, 1987 | K873745 | BAIR HUGGER(TM) - PATIENT WARMING SYSTEM Augustine Medical, Inc. | DWJ |
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