Medivance, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Arctic Sun Temperature Management System (Model 5000), Arctic Sun Stat Temperature Management System, Arctic Sun Stat Temperature Management System
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medivance, Inc. Cardiovascular ✕
10 devices
Cleared
Oct 24, 2025
Arctic Sun Temperature Management System (Model 5000)
Cardiovascular
120d
Cleared
Apr 30, 2025
Arctic Sun Stat Temperature Management System
Cardiovascular
131d
Cleared
Feb 28, 2020
Arctic Sun Stat Temperature Management System
Cardiovascular
29d
Cleared
Sep 02, 2016
Arctic Sun Temperature Management System
Cardiovascular
85d
Cleared
Dec 18, 2014
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS,...
Cardiovascular
87d
Cleared
Jul 20, 2012
HYBRID ARCTICGEL PAD
Cardiovascular
122d
Cleared
Jul 16, 2010
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
Cardiovascular
87d
Cleared
Aug 03, 2007
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
Cardiovascular
81d
Cleared
Mar 07, 2001
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
Cardiovascular
30d
Cleared
Oct 26, 2000
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT...
Cardiovascular
69d