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Medivance, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K251974 Arctic Sun Temperature Management System (Model 5000)DWJ2025-10-24 View
510(k) K243942 Arctic Sun Stat Temperature Management SystemDWJ2025-04-30 View
510(k) K200225 Arctic Sun Stat Temperature Management SystemDWJ2020-02-28 View
510(k) K161602 Arctic Sun Temperature Management SystemDWJ2016-09-02 View
510(k) K120849 HYBRID ARCTICGEL PADDWJ2012-07-20 View
510(k) K110956 MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSORFLL2011-07-18 View
510(k) K101092 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000DWJ2010-07-16 View
510(k) K080899 ARCTIC BLAST INTRAVENOUS FLUID CHILLERNCX2008-08-07 View
510(k) K071341 MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000DWJ2007-08-03 View
510(k) K010338 ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200DWJ2001-03-07 View
510(k) K002577 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADSDWJ2000-10-26 View
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