Home / Companies / Amsel Medical Corporation

Amsel Medical Corporation

FDA Regulatory Profile

Amsel Medical Corporation has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 20, 2019 · VAI
Latest 510(k)
Nov 15, 2018

Reviewing Amsel Medical Corporation 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 Amsel Medical Corporation'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
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 20, 2019Cambridge, MADevicesVoluntary Action Indicated (VAI)3008989837

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
K180650Amsel Endo OccluderNov 15, 2018
K172479Amsel Occluder DeviceSep 14, 2017
K140932AMSEL OCCLUDER DEVICEJan 23, 2015

FDA data resources