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MEDA Co., Ltd.

FDA Regulatory Profile

MEDA Co., Ltd. has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 13, 2019 · NAI
Latest 510(k)
Nov 18, 2021

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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 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 13, 2019Tianjin, ChinaDevicesNo Action Indicated (NAI)3006540052

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
K213070MD-320W Ultrasound BiomicroscopeNov 18, 2021
K182460MD-6000P Bladder ScannerMay 6, 2019
K152318MD-2300S Ultrasonic A/B Scanner for OphthalmologyNov 17, 2015
K121243ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETERMay 3, 2013
K113304BLADDER SCANNERMar 23, 2012
K063472ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200Jan 31, 2007
K063433ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200Jan 29, 2007

FDA data resources