Data / Medical devices / United States / Neilmed Pharmaceuticals, Inc.
Neilmed Pharmaceuticals, Inc.: FDA-registered device maker in Santa Rosa, CA, United States, 2 510(k) clearances
Neilmed Pharmaceuticals, Inc. is registered with the FDA (registration 2954718) in Santa Rosa, CA, United States. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 19, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2954718
- FEI number
- 3002998723
- Address
- 5555 Mehta Dr, Santa Rosa, CA, United States, 95403
- Owner or operator
- NEILMED PHARMACEUTICALS, INC. (9041036)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 12, 2000
- Registered through
- 2026
- Brand names listed
- Baby Nasakleen, Breath ease XL (Nasal/Sinus moisturizer and irrigation solution) Packets, Breath ease XL Jar (Nasal/Sinus moisturizing and irrigation formula), CVS SALINE Nasal Mist, CVS SALINE Nasal Mist;, CVS Sinus CLN WASH;, CVS Sinus WSH REF;, ClearCanal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Ent | KCJ | 1 | Manufacturer | accessdata.fda.gov |
| Device, Inflation, Middle Ear | MJV | U | Manufacturer | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Ear Irrigation Kit | OGQ | 1 | Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Manufacturer | accessdata.fda.gov |
| Irrigator, Powered Nasal | KMA | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Nasal Spray, Ent Delivery | KCO | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Ent | KCP | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 19, 2021 | K203754 | Eustachi Ear Pressure Relief Device | MJV | Substantially Equivalent | Exercore, LLC | accessdata.fda.gov |
| October 29, 2013 | K123910 | WOUNDWASH SALINE SPRAY | FRO | Substantially Equivalent | Neilmed Pharmaceuticals, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 28, 2024 | 96076 | Class II | Ongoing | NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formul | Due to nasal spray stability failure for bioburden. | accessdata.fda.gov |
Compare with other makers
- All makers of Fiber, Medical, Absorbent
- All makers of Applicator, Ent
- All makers of Nasal Spray, Ent Delivery
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Ear Irrigation Kit
- All makers of Irrigator, Powered Nasal
Updated February 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.