Aktina Medical Corp.

FDA Regulatory Profile

Aktina Medical Corp. has 0 FDA recalls, 3 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 24, 2017 · VAI
Latest 510(k)
Sep 25, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances4Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 24, 2017Congers, NYDevicesVoluntary Action Indicated (VAI)1000521490
Feb 12, 2013Congers, NYDevicesVoluntary Action Indicated (VAI)1000521490
Nov 6, 2009Congers, NYDevicesNo Action Indicated (NAI)1000521490

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
K192102Thermoplastic MasksSep 25, 2019
K161984Interlocked Circular Small Field Collimators, Elekta IntegratedSep 27, 2016
K151097Active Breathing CoordinatorMay 15, 2015
K131313ACTIVE BREATHING COORDINATORAug 7, 2013