Curatia Medical Co.

FDA Regulatory Profile

Curatia Medical Co. has 0 FDA recalls, 3 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 4, 2023 · NAI
Latest 510(k)
Apr 27, 2022

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections3Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 4, 2023Sunnyvale, CADevicesNo Action Indicated (NAI)3008361782
Feb 3, 2020Sunnyvale, CADevicesNo Action Indicated (NAI)3008361782
Mar 19, 2015Suzhou, ChinaDevicesNo Action Indicated (NAI)3008261722

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
K220604EXTesia Introducer Sheath SetApr 27, 2022
K180797Xcess Guiding CatheterDec 14, 2018
K171290Vela RX PTA Balloon Dilatation CatheterJul 19, 2017