NUANCE MEDICAL, LLC

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 3010543854

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010543854
FEI Number
3010543854
Entity Name
NUANCE MEDICAL, LLC
City/State/Country
Carlsbad, CA, US
Establishment Address
5931 Sea Lion Place, Suite 113, Carlsbad, CA 92010, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Nuance Medical, LLC (Owner Number: 10045112)
Owner / Operator Contact Address
5931 Sea Lion Place, Suite 113, Carlsbad, CA 92010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161337
PMA Number
N/A

All Registered Proprietary Names

Pain Freeze II Hurri-Freeze Spill Kits Ear Wash System Ear Wash Basin

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MLY Vapocoolant Device Unknown Class U N/A 2025-12-10
PXG Spill Kit General Hospital Class 1 880.6890 2024-04-03
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 2017-07-21
FNY Basin, Emesis General Hospital Class 1 880.6730 2017-07-21
MLY Vapocoolant Device Unknown Class U N/A 2016-12-08
GEH Unit, Cryosurgical, Accessories General, Plastic Surgery Class 2 878.4350 2016-08-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nuance Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190651 Erbe Elektromedizin GmbH ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter 2020-01-07
K760953 Spembly Medical , Ltd. DEEP FREEZE SYSTEM (DFS-30) 1976-11-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010543854. Last updated year: 2026. Please use registration number 3010543854 when referencing this establishment in official correspondence.
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