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Medivance Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
12
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2457-2024Class IIArctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun SJune 27, 2024
Z-1381-2024Class IIMedivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CFebruary 16, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K251974Arctic Sun Temperature Management System (Model 5000)October 24, 2025
K243942Arctic Sun Stat Temperature Management SystemApril 30, 2025
K200225Arctic Sun Stat Temperature Management SystemFebruary 28, 2020
K161602Arctic Sun Temperature Management SystemSeptember 2, 2016
K142702Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small UniDecember 18, 2014
K120849HYBRID ARCTICGEL PADJuly 20, 2012
K110956MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSORJuly 18, 2011
K101092ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000July 16, 2010
K080899ARCTIC BLAST INTRAVENOUS FLUID CHILLERAugust 7, 2008
K071341MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000August 3, 2007
K010338ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200March 7, 2001
K002577ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADSOctober 26, 2000