Home / Companies / Michelson Diagnostics, Ltd.

Michelson Diagnostics, Ltd.

FDA Regulatory Profile

Michelson Diagnostics, Ltd. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 13, 2023 · OAI
Latest 510(k)
Aug 11, 2016

Reviewing Michelson Diagnostics, Ltd. 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.

Check this supplier

Or check Michelson Diagnostics, Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances2Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 13, 2023Maidstone, United KingdomDevicesOfficial Action Indicated (OAI)3007603861
Feb 2, 2017Maidstone, United KingdomDevicesVoluntary Action Indicated (VAI)3007603861

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.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3007603861Maidstone, United Kingdom2Dec 13, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K153283VivoSight Dx Topical OCT SystemAug 11, 2016
K093520VIVOSIGHT TOPICAL OCT SYSTEMJan 5, 2010

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.