Home / Companies / Osko, Inc.

Osko, Inc.

FDA Regulatory Profile

Osko, Inc. has 0 FDA recalls, 2 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 3, 2019 · NAI
Latest 510(k)
Jun 29, 2020

Reviewing Osko, Inc. 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 Osko, Inc.'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) clearances6Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 3, 2019Medley, FLDevicesNo Action Indicated (NAI)3010666400
Aug 17, 2017Medley, FLDevicesVoluntary Action Indicated (VAI)3010666400

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
K201503Edge Air(1417) Digital Flat Panel X-ray DetectorJun 29, 2020
K172681Edge Air Digital Flat Panel X-ray DetectorOct 6, 2017
K172682Edge Digital Flat Panel X-ray DetectorOct 6, 2017
K163048Smart Stitching Software System, Image Processing, RadiologicalJul 28, 2017
K150663Diagnostic X-ray SystemMay 7, 2015
K150506ELIAN Digital Diagnostic X-ray SystemApr 8, 2015

FDA data resources