Company ยท US
Medivance, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 24, 2025 | K251974 | Arctic Sun Temperature Management System (Model 5000) Medivance, Inc. | DWJ |
| Apr 30, 2025 | K243942 | Arctic Sun Stat Temperature Management System Medivance, Inc. | DWJ |
| Feb 28, 2020 | K200225 | Arctic Sun Stat Temperature Management System Medivance, Inc. | DWJ |
| Sep 2, 2016 | K161602 | Arctic Sun Temperature Management System Medivance, Inc. | DWJ |
| Dec 18, 2014 | K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad Medivance, Inc. | DWJ |
| Jul 20, 2012 | K120849 | HYBRID ARCTICGEL PAD Medivance, Inc. | DWJ |
| Jul 18, 2011 | K110956 | MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR Medivance, Inc. | FLL |
| Jul 16, 2010 | K101092 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 Medivance, Inc. | DWJ |
| Aug 7, 2008 | K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER Medivance, Inc. | NCX |
| Aug 3, 2007 | K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 Medivance, Inc. | DWJ |
| Mar 7, 2001 | K010338 | ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 Medivance, Inc. | DWJ |
| Oct 26, 2000 | K002577 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS Medivance, Inc. | DWJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 31, 2024 | Medivance Inc. Arctic Sun Temperature Management Systems, Name/REF:
Arctic Sun STAT, NA/6000-00-00;
Arctic Sun STAT Loaner, NA/6000-00-00L;
Arctic Sun Stat EU UK/600001;
Arctic Sun Stat Taiwan/600006;
Arctic Sun St Open, Classified |
DWJ | K161602 K200225 |
| Mar 26, 2024 | Medivance Inc. Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C Open, Classified |
DWJ | K142702 |
| Jan 26, 2005 | MEDIVANCE INC. Arctic Sun Temperature Management System Terminated |
DWJ | K002577 K010338 |