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Graftys

FDA Regulatory Profile

Graftys has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 1 compliance action on record.

Latest inspection
Mar 7, 2013 · OAI
Latest 510(k)
Jul 12, 2023

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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) clearances5Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 7, 2013LYON, FranceDevicesOfficial Action Indicated (OAI)3006761298

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
K231714Graftys QuicksetJul 12, 2023
K093343GRAFTY QUICKSETApr 22, 2010
K082498GRAFTYS HBSFeb 25, 2009
K082286BIOACTYSFeb 24, 2009
K073064GRAFTYS BCPMar 11, 2008

FDA data resources