Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FMI 2021-04-22

Verifine Safety Type Insulin Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K210065

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MQV 2021-04-21

si-Mochi

Applicant Biostone, Ltd.

K-Number K202639

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QIH 2021-04-21

Preview Shoulder

Applicant Genesis Software Innovations

K-Number K210556

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DQX 2021-04-21

VASSALLO GT

Applicant Filmecc Co., Ltd.

K-Number K203533

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KGN 2021-04-21

InnovaMatrix FS

Applicant Triad Life Sciences, Inc.

K-Number K210580

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FXX 2021-04-21

Disposable medical surgical mask

Applicant Chongqing Coe Display Technology Co., Ltd.

K-Number K202759

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PBX 2021-04-21

NuEra Tight RF, NuEra Tight RF Plus

Applicant Bios S.R.L.

K-Number K210867

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FDF 2021-04-21

DiLumen Endolumenal Interventional Platform (DiLumen)

Applicant Lumendi, LLC

K-Number K210851

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JWH 2021-04-21

U2 Total Knee System, XPE Tibial Insert, PS PLUS

Applicant United Orthopedic Corporation

K-Number K210961

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LZA 2021-04-21

Nitrile Glove Powder Free Blue

Applicant Changzhou Universal Medical Equipment Co., Ltd.

K-Number K210145

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SBF 2021-04-21

Knee+

Applicant Pixee Medical

K-Number K202750

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JWH 2021-04-21

MOBIO Total Knee System

Applicant B-One Ortho, Corp.

K-Number K210483

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