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

GEI 2020-12-14

PlaDuo System

Applicant ShenB Co., Ltd.

K-Number K201735

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FQH 2020-12-14

Irrisept Wound Debridement and Cleansing System

Applicant Irrimax Corporation

K-Number K202222

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DQY 2020-12-14

Ventrax Delivery System

Applicant Merit Medical Systems, Inc.

K-Number K202610

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HRS 2020-12-14

Javelin Tailor's Bunion Fixation System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K202657

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MNR 2020-12-14

Maxxi Flow Sensor

Applicant Neurovirtual USA, Inc.

K-Number K201495

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DQA 2020-12-14

Fingertip Pulse Oximeter

Applicant Shenzhen Bsx Technology Electronics Co., Ltd.

K-Number K202324

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MOF 2020-12-14

Columbus Guidewire

Applicant Rapid-Medical , Ltd.

K-Number K200374

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QBD 2020-12-14

DNA/RNA Shield Collection Tube

Applicant Zymo Research

K-Number K202641

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GDW 2020-12-14

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

Applicant Fengh Medical Co., Ltd.

K-Number K202467

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DXX 2020-12-11

CorPath GRX System

Applicant Corindus, Inc.

K-Number K202275

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KTL 2020-12-11

NOVA Lite DAPI dsDNA Crithidia luciliae Kit

Applicant Inova Diagnostics, Inc.

K-Number K192916

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DSY 2020-12-11

exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft

Applicant Peca Labs

K-Number K202471

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