Medivance Inc.
FDA Regulatory Profile
Medivance Inc. appears in FDA public data with 2 recalls, 12 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2457-2024, Class II) was initiated on June 27, 2024. Its most recent 510(k) clearance was granted on October 24, 2025.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 12
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2457-2024 | Class II | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun S | June 27, 2024 |
| Z-1381-2024 | Class II | Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C | February 16, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251974 | Arctic Sun Temperature Management System (Model 5000) | October 24, 2025 |
| K243942 | Arctic Sun Stat Temperature Management System | April 30, 2025 |
| K200225 | Arctic Sun Stat Temperature Management System | February 28, 2020 |
| K161602 | Arctic Sun Temperature Management System | September 2, 2016 |
| K142702 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Uni | December 18, 2014 |
| K120849 | HYBRID ARCTICGEL PAD | July 20, 2012 |
| K110956 | MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR | July 18, 2011 |
| K101092 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 | July 16, 2010 |
| K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | August 7, 2008 |
| K071341 | MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 | August 3, 2007 |
| K010338 | ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 | March 7, 2001 |
| K002577 | ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS | October 26, 2000 |