Rodo Medical, Inc.

FDA Regulatory Profile

Rodo Medical, Inc. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 1 compliance action on record.

Latest inspection
Aug 1, 2014 · OAI
Latest 510(k)
Feb 27, 2020

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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
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 1, 2014San Jose, CADevicesOfficial Action Indicated (OAI)3009113203

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
K193274Rodo Abutment SystemFeb 27, 2020
K180609Rodo SmilekeyMay 23, 2018
K160786RODO Abutment SystemNov 21, 2016