Nuance Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232674PainFreeze IIFebruary 12, 2024
K210310CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitOctober 22, 2021
K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayOctober 18, 2017
K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102November 22, 2016
K161337CryoDose H or SimilarJuly 12, 2016
K130995NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAYJune 14, 2013