Medivance, Inc.
Medivance, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2025, with 2 FDA device recalls on record.
Top product codes for Medivance, Inc.
FDA recalls by Medivance, Inc.
- Z-2457-2024 — Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun Stat EU UK/600001; Arctic Sun Stat Taiwan/600006; Arctic Sun Stat Japan/600020; Arctic Sun 5000, NA/5000-00-00; Arctic Sun 5000, NA w/ Transmission Interface Module/5000-00-00E; Loaner, Arctic Sun M5000, NA/5000-00-00L; Arctic Sun 5000, EU/5000-1-01; Loaner, Arctic Sun M5000, EU/5000-01-01L; Arctic Sun 5000, UK/5000-01-02; Arctic Sun 5000, Australia/5000-01-03; Arctic Sun 5000, China/5000-01-04; Arctic Sun 5000, Brazil/5000-01-05; Arctic Sun 5000, Switzerland/5000-01-07; Arctic Sun 5000, South Africa/5000-01-08
- Z-1381-2024 — Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Medivance, Inc.
- K251974 — Arctic Sun Temperature Management System (Model 5000)
- K243942 — Arctic Sun Stat Temperature Management System
- K200225 — Arctic Sun Stat Temperature Management System
- K161602 — Arctic Sun Temperature Management System
- K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
- K120849 — HYBRID ARCTICGEL PAD
- K110956 — MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
- K101092 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
- K080899 — ARCTIC BLAST INTRAVENOUS FLUID CHILLER
- K071341 — MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
- K010338 — ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
- K002577 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS
Data sourced from openFDA. This site is unofficial and independent of the FDA.