Radiomed Corporation

FDA Regulatory Profile

Radiomed Corporation has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 13, 2018 · NAI
Latest 510(k)
Apr 28, 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) clearances7Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 13, 2018Bartlett, TNDevicesNo Action Indicated (NAI)3004047528

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
K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)Apr 28, 2017
K120859PRE-LOADED GOLD VISICOIL CK MARKERApr 19, 2012
K070305PRE-LOADED VISICOILMar 7, 2007
K031206RADIOMED SOFT TISSUE MARKERMay 21, 2003
K022326RADIOMED MARKERJan 31, 2003
K013660GENETRADec 5, 2001
K001070RADIOMED SOURCEOct 24, 2000