Home / Companies / Keranetics

Keranetics

FDA Regulatory Profile

Keranetics has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 6, 2025 · VAI
Latest 510(k)
Jul 16, 2020

Reviewing Keranetics as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Request a free FDA snapshot

Or get Keranetics's full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 6, 2025Winston Salem, NCDevicesVoluntary Action Indicated (VAI)3015980493

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K192386KeraStat CreamJul 16, 2020
K162759KeraStat(R) GelJun 2, 2017

FDA data resources