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

KIF 2021-03-24

White ENDOSEAL MTA

Applicant Maruchi

K-Number K202015

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JAK 2021-03-24

Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System

Applicant Canon Medical Systems Corporation

K-Number K203225

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NFT 2021-03-24

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

Applicant Safecare Biotech (Hangzhou) Co., Ltd.

K-Number K202453

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FRC 2021-03-24

STERIZONE VP4 Test Pack

Applicant Tso3 Inc., Now A Part of Stryker

K-Number K203560

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FXX 2021-03-24

Medical disposable face mask non sterile

Applicant Guangdong Zhong Ling Industrial Group Co., Ltd.

K-Number K202650

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DQD 2021-03-23

MyHomeDoc

Applicant Myhomedoc , Ltd.

K-Number K202483

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OLO 2021-03-23

7D Surgical System - Drill Guide

Applicant 7D Surgical, Inc.

K-Number K210555

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GEI 2021-03-23

LigaSure Exact Dissector, Nano-coated

Applicant Covidien, LLC

K-Number K202917

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NRY 2021-03-23

Tigertriever and Tigertriever 17 Revascularization Devce

Applicant Rapid Medical , Ltd.

K-Number K203592

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QAS 2021-03-23

Viz ICH

Applicant Viz. Ai, Inc.

K-Number K210209

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GZJ 2021-03-23

TrueRelief Device

Applicant Truerelief

K-Number K202186

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OLO 2021-03-23

Navigated Spine Instruments

Applicant Stryker Spine

K-Number K203205

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