Myoscience Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2201-2015Class IIiovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iJuly 1, 2015
Z-1781-2013Class IIMyoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF CataloJune 21, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K173763iovera systemFebruary 28, 2018
K161835iovera systemMarch 24, 2017
K142866Myoscience iovera systemJanuary 21, 2015
K133453IOVERAMarch 24, 2014
K123516CRYO-TOUCH IVJanuary 10, 2013
K120415CRYO-TOUCH IIIJune 22, 2012
K102021CRYO-TOUCH IISeptember 17, 2010
K100447MYOSCIENCE CRYO-TOUCHJune 25, 2010
K083493MYOSCIENCE CRYO-TOUCHMarch 20, 2009