Nuance Medical, LLC
Carlsbad, CA, US
NUANCE MEDICAL, LLC appears in FDA device records in Carlsbad, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Nuance Medical, LLC between 2013 and 2024. The busiest year on record is 2016, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232674 | PainFreeze II | MLY | Substantially Equivalent | |
| K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit | GEH | Substantially Equivalent | |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | MLY | Substantially Equivalent | |
| K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 | MLY | Substantially Equivalent | |
| K161337 | CryoDose H or Similar | GEH | Substantially Equivalent | |
| K130995 | NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY | GEH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010543854 | 3010543854 | NUANCE MEDICAL, LLC | 5931 Sea Lion Place, Carlsbad, CA 92010 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain