LGZ · Class II · 21 CFR 880.5725

FDA Product Code LGZ: Warmer, Thermal, Infusion Fluid

Leading manufacturers include Belmont Instrument Corp., Quality IN Flow , Ltd. and STERIS Corporation.

75
Total
75
Cleared
176d
Avg days
1981
Since
75 devices
25–48 of 75
Cleared Jul 12, 2012
BW685, BW685S
K121198
Biegler GmbH
General Hospital · 84d
Cleared May 08, 2012
PERFORMER HT/ HANG&GO HT BASIC
K120026
Rand S.R.L.
General Hospital · 126d
Cleared May 08, 2012
INFU BOX TYPE 0412A
K120860
Medical Rescue Equipment Holding AS
General Hospital · 47d
Cleared Mar 29, 2012
IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS
K112702
Imperial Surgical , Ltd.
General Hospital · 195d
Cleared Mar 14, 2012
ENFLOW IV FLUID WARMER
K112902
Vital Signs, Inc.
General Hospital · 162d
Cleared Jul 29, 2011
AMSCO WARMING CABINET
K111870
STERIS Corporation
General Hospital · 28d
Cleared Jun 03, 2011
AMSCO WARMING CABINET
K110769
STERIS Corporation
General Hospital · 77d
Cleared May 20, 2011
HYPOTHERMX INTRAVENOUS FLUID WARMER
K103801
Emit Corporation
General Hospital · 143d
Cleared May 07, 2010
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
K091336
Enthermics Medical Systems, Inc.
General Hospital · 366d
Cleared Mar 04, 2010
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
K092366
Thermal Therapeutic Systems, Inc.
General Hospital · 211d
Cleared Dec 18, 2009
AMSCO WARMING CABINET
K092823
STERIS Corporation
General Hospital · 95d
Cleared Feb 12, 2009
BELMONT HYPERTHERMIA PUMP
K090089
Belmont Instrument Corp.
General Hospital · 29d
Cleared Dec 18, 2008
ASTOFLO PLUS
K082765
Stihler Electronic GmbH
General Hospital · 87d
Cleared Oct 06, 2008
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
K082217
Arizant Healthcare, Inc.
General Hospital · 61d
Cleared Jun 02, 2008
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
K072080
Smiths Medical Asd, Inc.
General Hospital · 308d
Cleared Mar 20, 2008
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300
K073363
Paladin Biomedical Corporation
General Hospital · 111d
Cleared Sep 11, 2007
FLEXWARMER, MODELS KZ-1 AND KZ-2
K062644
Merlyn Associates, Inc.
General Hospital · 370d
Cleared Jun 08, 2007
HYPERTHERMIA PUMP
K070654
Belmont Instrument Corp.
General Hospital · 91d
Cleared Dec 22, 2006
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER
K060851
The Smithworks Company
General Hospital · 269d
Cleared Oct 26, 2006
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
K052055
Smisson-Cartledge Biomedical, LLC
General Hospital · 454d
Cleared Jun 26, 2006
RANGER IRRIGATION FLUID WARMING SYSTEM
K060939
Arizant Healthcare, Inc.
General Hospital · 81d
Cleared Jun 08, 2006
EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
K060537
Enginivity, LLC
General Hospital · 100d
Cleared Feb 15, 2005
8NONE
K041839
Medical Solutions, Inc.
General Hospital · 222d
Cleared Sep 22, 2003
LARGE VOLUME FLUID RESERVOIR
K032778
Belmont Instrument Corp.
General Hospital · 14d