Company · US
Nuance Medical, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2024. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 2024 | K232674 | PainFreeze II Nuance Medical, LLC | MLY |
| Oct 22, 2021 | K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit Nuance Medical, LLC | GEH |
| Oct 18, 2017 | K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray Nuance Medical, LLC | MLY |
| Nov 22, 2016 | K162218 | Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102 Nuance Medical, LLC | MLY |
| Jul 12, 2016 | K161337 | CryoDose H or Similar Nuance Medical, LLC | GEH |
| Jun 14, 2013 | K130995 | NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY Nuance Medical, LLC | GEH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||