Control-X Medical, Inc.

FDA Regulatory Profile

Control-X Medical, Inc. has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Sep 9, 2019 · VAI
Latest 510(k)
Oct 22, 2010

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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) clearances1Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Control-X Medical Zrt
Same company group
0010—

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 9, 2019Columbus, OHDevicesVoluntary Action Indicated (VAI)1000122630
Sep 30, 2016Columbus, OHDevicesVoluntary Action Indicated (VAI)1000122630
Apr 20, 2011Columbus, OHDevicesNo Action Indicated (NAI)1000122630

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 1000122630Columbus, OH3Sep 9, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K102680Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEMOct 22, 2010

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