510(k) clearances for Warmer, Thermal, Infusion Fluid
75 on file
- Mequ A/SApr 24, 2026
K260988 · °M Warmer System with °M Station
- The Surgical Company International B.V.Nov 18, 2025
K252636 · Fluido Compact System
- The Surgical Company International BV (As Tsc Life)Sep 4, 2025
K251733 · Fluido® AirGuard System
- Mequ A/SMay 31, 2024
K232107 · °M Warmer System
- The Surgical Company International B.V.Jun 5, 2023
K211618 · Fluido Compact Blood and Fluid Warming System
- Quality IN Flow , Ltd.Dec 8, 2022
K211800 · Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
- Smisson-Cartledge Biomedical, LLCAug 12, 2022
K202461 · ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
- Barkey GmbH & Co. KGMay 24, 2022
K213191 · S-Line
- Life Warmer, Inc.Oct 18, 2019
K192325 · Quantum Blood and Fluid Warming System
- Mac Medical, Inc.Mar 5, 2019
K180842 · MAC Medical D-Series Blanket and Solution Warming Cabinets
- Life Warmer, Inc.Jan 28, 2019
K181775 · Quantum Blood and IV Fluid Infusion Warmer
- Quality IN Flow , Ltd.Apr 27, 2018
K180154 · QiF Blood and Fluid Warmer
- Quality IN Flow , Ltd.Sep 27, 2017
K171215 · QiF Blood and Fluid Warmer
- Quality IN Flow , Ltd.Apr 20, 2017
K163708 · QiF Blood and Fluid Warmer
- Rand S.R.L.Dec 28, 2016
K161613 · Hang&Go PAC
- Quality IN Flow , Ltd.Jun 23, 2016
K150404 · QiF Blood and Fluid Warmer
- Belmont Instrument CorporationSep 2, 2015
K152208 · The Belmont Hyperthermia Pump
- Creche InnovationsJul 9, 2015
K150484 · Penguin In-Line Warmer
- Enthermics Medical Systems, Inc.Dec 6, 2013
K132202 · DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
- Belmont Instrument Corp.Nov 6, 2013
K131519 · BELMONT HYPERTHERMIA PUMP
- Natus Nicolet Ireland, Ltd.Oct 3, 2013
K132110 · NATUS WARMETTE BLANKET AND DUAL CABINETS
- Vital Signs, Inc., A GE Healthcare CompanyJun 14, 2013
K130867 · ENFLOW IV FLUID WARMER INSULATED STRAP
- Acacia, Inc.Jun 13, 2013
K122449 · ENTERAL NUTRITION WARMER
- Vital Signs, Inc., A GE Healthcare CompanyNov 28, 2012
K121775 · ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER
- Biegler GmbHJul 12, 2012
K121198 · BW685, BW685S
- Rand S.R.L.May 8, 2012
K120026 · PERFORMER HT/ HANG&GO HT BASIC
- Medical Rescue Equipment Holding ASMay 8, 2012
K120860 · INFU BOX TYPE 0412A
- Imperial Surgical , Ltd.Mar 29, 2012
K112702 · IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
- Hei, Inc.Mar 21, 2012
K102900 · HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM
- Vital Signs, Inc.Mar 14, 2012
K112902 · ENFLOW IV FLUID WARMER
- STERIS CorporationJul 29, 2011
K111870 · AMSCO WARMING CABINET
- STERIS CorporationJun 3, 2011
K110769 · AMSCO WARMING CABINET
- Emit CorporationMay 20, 2011
K103801 · HYPOTHERMX INTRAVENOUS FLUID WARMER
- Enthermics Medical Systems, Inc.May 7, 2010
K091336 · IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
- Thermal Therapeutic Systems, Inc.Mar 4, 2010
K092366 · TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
- STERIS CorporationDec 18, 2009
K092823 · AMSCO WARMING CABINET
- Belmont Instrument Corp.Feb 12, 2009
K090089 · BELMONT HYPERTHERMIA PUMP
- Stihler Electronic GmbHDec 18, 2008
K082765 · ASTOFLO PLUS
- Arizant Healthcare, Inc.Oct 6, 2008
K082217 · RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
- Smiths Medical Asd, Inc.Jun 2, 2008
K072080 · NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
- Paladin Biomedical CorporationMar 20, 2008
K073363 · THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300
- Merlyn Associates, Inc.Sep 11, 2007
K062644 · FLEXWARMER, MODELS KZ-1 AND KZ-2
- Belmont Instrument Corp.Jun 8, 2007
K070654 · HYPERTHERMIA PUMP
- The Smithworks CompanyDec 22, 2006
K060851 · SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER
- Smisson-Cartledge Biomedical, LLCOct 26, 2006
K052055 · SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
- Arizant Healthcare, Inc.Jun 26, 2006
K060939 · RANGER IRRIGATION FLUID WARMING SYSTEM
- Enginivity, LLCJun 8, 2006
K060537 · EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
- Medical Solutions, Inc.Feb 15, 2005
K041839 · 8NONE
- Belmont Instrument Corp.Sep 22, 2003
K032778 · LARGE VOLUME FLUID RESERVOIR
- Belmont Instrument Corp.Sep 16, 2003
K032674 · BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
- Minimed, Inc.Jul 23, 2003
K031390 · MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
- Elltec Co., Ltd.Jan 28, 2003
K024373 · MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
- Automatic Medical Technologies, Inc.Jan 17, 2003
K023653 · MAXONE IV FLUID/BLOOD WARMER, MODEL 102
- Nxstage Medical, Inc.Oct 24, 2001
K012832 · COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200
- Elltec Co., Ltd.Oct 9, 2001
K012906 · ANIMEC, MODELS AM-2S-4 AND AM-2S-5
- Medical Solutions, Inc.Aug 20, 2001
K012276 · TEMP 3
- Automatic Medical Technologies, Inc.Jun 28, 2001
K002409 · MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
- Sims Level 1, Inc.Aug 9, 2000
K001764 · HOTLINE 2 FLUID WARMER
- Medical Products, Inc.Jul 10, 1998
K981509 · TEMPO III
- SmithMar 10, 1998
K973748 · TEMPO AND TEMP H20
- Medical Solutions, Inc.Mar 10, 1998
K980086 · HEAT STACK
- Biegler Medical Products, Inc.Aug 8, 1996
K954769 · BIEGLER BW385L BLOOD & INFUSION WARMER
- C.F. Electronics, Inc.May 14, 1996
K955659 · DRUGBOX
- C.F. Electronics, Inc.Jan 27, 1993
K922786 · THERM O DRUG MODEL HT-747
- Microwave Medical Systems, Inc.Oct 23, 1992
K914867 · QWIK-1(TM) IN-LINE IV FLUID WARMER
- North American Technical Services Corp.Sep 10, 1992
K914364 · ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.
- C.F. Electronics, Inc.Sep 2, 1992
K921395 · HOT SACK
- Level 1 Technologies, Inc.Oct 17, 1991
K911383 · HOTLINE FLUID WARMER
- Medadvances, Inc.Oct 15, 1990
K904252 · HEATWAVE
- Medadvances, Inc.Feb 9, 1990
K896018 · BIOTEMP
- Pmt Corp.Feb 28, 1989
K883873 · INFUSION FLUID WARMER
- Stihler Electronic, C/O Worldwide Regul. ServicesAug 25, 1988
K882361 · STIHLER ASTOTHERM IFT 200, IFT 220
- Electromedics, Inc.Aug 20, 1982
K822098 · BT 794-BLOOD/FLUID WARMER
- Datachem, Inc.Dec 9, 1981
K813161 · FLO TEM II (BLOOD/FLUID WARMER
- Datachem, Inc.May 21, 1981
K803249 · FLUID WARMER