510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Neilmed Pharmaceuticals Inc

Santa Rosa, CA, US

NEILMED PHARMACEUTICALS, INC. appears in FDA device records in Santa Rosa, CA. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
1
Registered establishments
2

510(k) clearance history

FDA records hold 1 510(k) clearance for Neilmed Pharmaceuticals Inc in 2013.

Clearances by year, as a table
510(k) clearance decisions for Neilmed Pharmaceuticals Inc, by decision year
YearClearances
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K123910WOUNDWASH SALINE SPRAYFROSubstantially Equivalent

Registered establishments

FDA registered establishments for Neilmed Pharmaceuticals Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29547183002998723NEILMED PHARMACEUTICALS, INC.5555 Mehta Dr, Santa Rosa, CA 95403 US2026
30262387843026238784NEILMED PHARMACEUTICALS, INC.981 S WANAMAKER AVE., Ontario, CA 91761 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1105-2025NeiMed 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 formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.Due to nasal spray stability failure for bioburden.Class IIOpen, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

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Data as of , FDA export datePage updated Source: openFDA, public domain