Home / Companies / Viscus Biologics, LLC

Viscus Biologics, LLC

FDA Regulatory Profile

Viscus Biologics, LLC has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 22, 2026 · NAI
Latest 510(k)
Feb 27, 2019

Reviewing Viscus Biologics, LLC 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 Viscus Biologics, LLC'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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 22, 2026Warrensville Heights, OHDevicesNo Action Indicated (NAI)3013012623
May 9, 2024Warrensville Heights, OHDevicesNo Action Indicated (NAI)3013012623

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
K190155FibermarX Radiopaque Tissue MarkerFeb 27, 2019
K170026Radiopaque Tissue MarkerJun 2, 2017
K140820XENOMEM WOUND MATRIXJun 26, 2015

FDA data resources