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Dallen Medical, Inc.

FDA Regulatory Profile

Dallen Medical, Inc. has 0 FDA recalls, 1 inspection, 11 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 12, 2014 · NAI
Latest 510(k)
Nov 7, 2017

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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) clearances11Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 12, 2014San Clemente, CADevicesNo Action Indicated (NAI)3009596646

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
K171473Compressyn™ StapleNov 7, 2017
K150359Tensyn PlugMay 7, 2015
K143092Tensyn PlugFeb 11, 2015
K141264TENSYN BAND, TENSYN FRACTURE PLATESAug 21, 2014
K140358COMPRESSYN STAPLEJun 2, 2014
K133858TENSYN BANDFeb 28, 2014
K132875COMPRESSYN STAPLEDec 30, 2013
K131850TENSYN BANDNov 15, 2013
K130431COMPRESSYN BANDJul 25, 2013
K122871COMPRESSYN STAPLEFeb 7, 2013
K101484COMPRESSYN BANDApr 1, 2011

FDA data resources