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 |
|---|---|---|---|
| Feb 17, 2012 | K120081 | NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS Cincinnati Sub-Zero Products, Inc. | DWJ |
| Nov 23, 2011 | K112488 | HOTDOG PATIENT WARMING SYSTEM Augustine Biomedical & Design, LLC | DWJ |
| Jun 30, 2011 | K102856 | SIROCCO THERMAL REGULATING SYSTEM Galmaz Biotech S.L. | DWJ |
| Feb 4, 2011 | K110104 | BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM Cincinnati Sub-Zero Products, Inc. | DWJ |
| Jan 20, 2011 | K100585 | MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 Gaymar Industries, Inc. | DWJ |
| Nov 18, 2010 | K102112 | CRITICOOL PRO Mtre Advanced Technology , Ltd., IL | DWJ |
| Oct 19, 2010 | K093244 | UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX Geratherm Medical AG, DE | DWJ |
| Oct 1, 2010 | K101148 | WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS Cincinnati Sub-Zero Products, Inc. | DWJ |
| Sep 20, 2010 | K101589 | BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS Cincinnati Sub-Zero Products, Inc. | DWJ |
| Sep 20, 2010 | K093694 | GERATHERM UNIQUERESC Geratherm Medical AG, DE | DWJ |
| Jul 16, 2010 | K101092 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 Medivance, Inc. | DWJ |
| Jul 2, 2010 | K101705 | MISTRAL-AIR WARMING SYSTEM The Surgical Company International B.V., NL | DWJ |
| Jun 3, 2010 | K094056 | HOTDOG MULTI FUNCTION CONTROLLER Augustine Biomedical & Design, LLC | DWJ |
| Dec 10, 2009 | K092807 | HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 Augustine Biomedical & Design, LLC | DWJ |
| Jun 3, 2009 | K083336 | LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL Smiths Medical Asd, Inc. | DWJ |
| Mar 26, 2009 | K083662 | CRITICOOL Mtre Advanced Technology , Ltd., IL | DWJ |
| Oct 31, 2008 | K083135 | MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002 Thermogear, Inc. | DWJ |
| Jun 6, 2008 | K073712 | SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 Adroit Medical Systems, Inc. | DWJ |
| May 30, 2008 | K080763 | TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT Talley Medical | DWJ |
| Dec 7, 2007 | K072513 | DM-EMG Gvp Elettronica Srl | DWJ |
| Nov 9, 2007 | K071918 | CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002 Thermogear, Inc. | DWJ |
| Aug 3, 2007 | K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 Medivance, Inc. | DWJ |
| Jul 13, 2007 | K070112 | RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM Medcool, Inc. | DWJ |
| Dec 8, 2006 | K061902 | COSYTHERM, MODELS NCM1, NCM2, NCB1, CCU1, CRU1 Inditherm Medical | DWJ |
| Dec 7, 2006 | K062794 | PRN THERMALCARE, MODEL 3000 American Healthcare Products, Inc. | DWJ |
| Aug 1, 2006 | K061513 | LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET Smiths Medical Asd, Inc. | DWJ |
| Jun 29, 2006 | K051336 | GERATHERM SOS-RESCUE BAG R.G. Enterprises, Inc. | DWJ |
| Jun 29, 2006 | K051278 | GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE) Rg Ent., Inc. | DWJ |
| May 4, 2006 | K052392 | HOT DOG PATIENT WARMING SYSTEM Augustine Biomedical & Design, LLC | DWJ |
| Apr 27, 2006 | K051419 | INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 Inditherm Medical | DWJ |
| Apr 24, 2006 | K060865 | BAIR PAWS TEMPERATURE MANAGEMENT SYSTEM MODEL 850 Arizant Healthcare, Inc. | DWJ |
| Mar 9, 2006 | K053645 | MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS Arizant Healthcare, Inc. | DWJ |
| Feb 24, 2006 | K051097 | GERATHERM SOS-RESCUE BLANKET Rg Ent., Inc. | DWJ |
| Oct 12, 2004 | K031728 | KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET Klimamed Technologie Medizingerate GmbH | DWJ |
| Jun 30, 2004 | K041686 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM Arizant Healthcare, Inc. | DWJ |
| Jun 22, 2004 | K040911 | VITALHEAT Dynatherm Medical, Inc. | DWJ |
| Apr 27, 2004 | K040632 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 Smiths Medical Asd, Inc. | DWJ |
| Apr 27, 2004 | K040440 | HTTP SYSTEM (HTTP 2001 CONTROLLER AND HTTP WARM ME BLANKETS) Http Hypothermia Therapy, IL | DWJ |
| Nov 12, 2003 | K033021 | KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS Kimberly-Clark Corp. | DWJ |
| Feb 10, 2003 | K024128 | ALLON 2001 VERSION 5 Mtre Advanced Technology , Ltd. | DWJ |
| Jan 23, 2003 | K023934 | RAPID THERMAL EXCHANGE SYSTEM Avacore Technologies, Inc. | DWJ |
| Nov 27, 2002 | K022903 | CHILLBUSTER Microtek Medical, Inc. | DWJ |
| Aug 16, 2002 | K014210 | PALMO THERMOREGULATION INTERFACE ACCESSORY Avacore Technologies, Inc. | DWJ |
| Jul 9, 2002 | K021473 | BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM Augustine Medical, Inc. | DWJ |
| May 1, 2002 | K011859 | KLIMAMED THERMAL MAT & CONTROLLER 95 AND 55 WATTS Klimamed Technologie Medizingerate GmbH | DWJ |
| Apr 23, 2002 | K020604 | WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 Nellcor Puritan Bennett, Inc. | DWJ |
| Jan 11, 2002 | K014121 | WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860 Nellcor Puritan Bennett, Inc. | DWJ |
| Dec 18, 2001 | K011907 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM Sims Level 1, Inc. | DWJ |
| Mar 7, 2001 | K010338 | ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 Medivance, Inc. | DWJ |
| Jan 19, 2001 | K003368 | ACROTHERM Aquarius Medical Corp. | DWJ |
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