ClearanceBrief
Panels › General Hospital › Product code LGZ · Class 2

Warmer, Thermal, Infusion Fluid

Regulation 880.5725

3510(k)s in 12 months (76 all time)
1recalls in 12 months (33 all time)
31recalls that name a 510(k)
Get daily alerts for LGZSample briefCSV

Top companies in LGZ

DateFirm and productCodeLinked 510(k)
Jul 17, 2026ICU Medical Inc.
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow
Open, Classified
LGZK911383
Aug 1, 20253M Company
3M Ranger Irrigation Fluid Warming Set, REF 24750
Open, Classified
LGZK060939
Apr 25, 2025Belmont Instrument LLC
Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-000
Open, Classified
LGZK152208
Apr 25, 2025Belmont Instrument LLC
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 Heat Exchanger/Patient Line set (P/N 403-00382). The
Open, Classified
LGZK242735
Apr 25, 2025Belmont Instrument LLC
Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Straight Inflow/Outflow Patient Line Kit (P/N 902-00037)
Open, Classified
LGZK152208
Apr 25, 2025Belmont Instrument LLC
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter
Open, Classified
LGZK152208
Aug 6, 2021Smiths Medical ASD Inc.
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Open, Classified
LGZK072080
Aug 6, 2021Smiths Medical ASD Inc.
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Open, Classified
LGZK072080
Jun 4, 2021Eight Medical International BV
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the temperature of the thoracic or peritoneal cavity to a t
Terminated
LGZK102900
Apr 30, 2021RanD S.r.l.
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Terminated
LGZNone listed
Apr 30, 2021RanD S.r.l.
Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
Terminated
LGZK161613
Mar 26, 2021Smisson-Cartledge Biomedical, LLC
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including p
Terminated
LGZK052055
Mar 26, 2021Smisson-Cartledge Biomedical, LLC
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including p
Terminated
LGZK052055
Mar 26, 2021Smisson-Cartledge Biomedical, LLC
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including pa
Terminated
LGZK052055
Jun 26, 2019Vyaire Medical
enFlow Disposable Cartridge with IV Extension Set, used for intravenous warming therapy with fluid and blood solutions.
Terminated
LGZK060537
K130867
Jun 26, 2019Vyaire Medical
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Terminated
LGZK060537
K130867
Oct 31, 2016Smiths Medical ASD, Inc.
HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's
Terminated
LGZNone listed
Oct 15, 2016Natus Manufacturing Limited
Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hospital linens; while, the Natus Warmette Dual Cabinet is design
Terminated
LGZK132110
Nov 20, 2015Steris Corporation
AMSCO Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obst
Terminated
LGZK111870
Apr 9, 2014Smiths Medical ASD, Inc.
Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Terminated
LGZK911383
Apr 9, 2014Smiths Medical ASD, Inc.
Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
Terminated
LGZK911383
Jul 9, 2012Vital Signs Devices, a GE Healthcare Company
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended
Terminated
LGZK060537
Jul 9, 2012Smiths Medical ASD, Inc.
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE 3 Blood and Fluid Warmer. This product, for use in conjunction with HOT
Terminated
LGZK911383
Jan 11, 2012Smiths Medical ASD, Inc.
Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast
Terminated
LGZK911383
Jan 11, 2012Smiths Medical ASD, Inc.
Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1 Fast
Terminated
LGZK911383
Jan 11, 2012Smiths Medical ASD, Inc.
HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood an
Terminated
LGZK911383
Jan 11, 2012Smiths Medical ASD, Inc.
HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood a
Terminated
LGZK911383
Jan 11, 2012Smiths Medical ASD, Inc.
HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood a
Terminated
LGZK911383
Jan 11, 2012Smiths Medical ASD, Inc.
HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood
Terminated
LGZK911383
Jan 11, 2012Smiths Medical ASD, Inc.
HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood an
Terminated
LGZK911383
Aug 19, 2011Vital Signs Devices, a GE Healthcare Company
enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood
Terminated
LGZK060537
Sep 3, 2010Vital Signs Inc
Vital Signs Inc. enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical point-of-care device designed to warm blood and IV fluids.
Terminated
LGZK060537
Sep 4, 2009Enginivity LLC
Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.
Terminated
LGZK060537

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.