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Uzinmedicare Co.

FDA Regulatory Profile

Uzinmedicare Co. has 0 FDA recalls, 1 inspection, 12 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 10, 2015 · VAI
Latest 510(k)
Jun 4, 2026

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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) clearances12Oct 4, 2026Not statedCurrent
Inspections1Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 10, 2015Sungnam Si, Korea (The Republic Of)DevicesVoluntary Action Indicated (VAI)3008604531

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
K260956Spectra Platinum MiniJun 4, 2026
K250208SPECTRA Wearable 2Apr 6, 2026
K251423Spectra S1 Pro; Spectra S2 ProFeb 6, 2026
K251932Spectra PlatinumNov 25, 2025
K220926Spectra WearableDec 12, 2022
K210124Synergy Gold (SG) Portable (Models MM011450 and MM011460)Oct 19, 2021
K191109Spectra QJan 22, 2020
K191208Spectra CashmereOct 11, 2019
K181784Spectra S3 PlusNov 30, 2018
K162415Spectra 9PlusMar 15, 2017
K150476Spectra S1Plus and Spectra S2 PlusApr 15, 2016
K093145SPECTRA SERIES BREAST PUMPAug 13, 2010

FDA data resources