Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Asahi KaseiLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Medivance with 13 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Oct 30, 2026: Arctic Sun™ Neonatal ArcticGel™ Pad.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 30, 2026 | Arctic Sun™ Neonatal ArcticGel™ PadK263587 · DWJ | 510(k) clearances |
| Oct 24, 2025 | Arctic Sun Temperature Management System (Model 5000)K251974 · DWJ | 510(k) clearances |
| Apr 30, 2025 | Arctic Sun Stat Temperature Management SystemK243942 · DWJ | 510(k) clearances |
| Jun 27, 2024 | Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Class II · If temperature management system fails to reach correct target water temperature while device is operating in patient co | Device recalls |
| Feb 16, 2024 | Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CClass II · Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of | Device recalls |
| Feb 28, 2020 | Arctic Sun Stat Temperature Management SystemK200225 · DWJ | 510(k) clearances |
| Sep 2, 2016 | Arctic Sun Temperature Management SystemK161602 · DWJ | 510(k) clearances |
| Dec 18, 2014 | Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel PadK142702 · DWJ | 510(k) clearances |
| Jul 20, 2012 | HYBRID ARCTICGEL PADK120849 · DWJ | 510(k) clearances |
| Jul 18, 2011 | MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSORK110956 · FLL | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
