Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Nuance Medical, LLC with 6 510(k) clearances. The most recent is a 510(k) clearance dated Feb 12, 2024: PainFreeze II.
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.
| Feb 12, 2024 | PainFreeze IIK232674 · MLY | 510(k) clearances |
| Oct 22, 2021 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister KitK210310 · GEH | 510(k) clearances |
| Oct 18, 2017 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayK172203 · MLY | 510(k) clearances |
| Nov 22, 2016 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102K162218 · MLY | 510(k) clearances |
| Jul 12, 2016 | CryoDose H or SimilarK161337 · GEH | 510(k) clearances |
| Jun 14, 2013 | NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAYK130995 · GEH | 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
