Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

IYN 2021-06-25

Apache Ultrasound System

Applicant Aco Healthcare Co., Ltd.

K-Number K211232

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QKA 2021-06-25

iTind System

Applicant Medi-Tate , Ltd.

K-Number K210138

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FMI 2021-06-25

Safety Winged Blood Collection Sets

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K211293

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IYO 2021-06-25

BD Prevue II Peripheral Vascular Vascular Access System

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K-Number K211193

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DQK 2021-06-25

iLab Polaris Multi-Modality Guidance System

Applicant Boston Scientific Corporation

K-Number K210889

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IYO 2021-06-24

THD Procto Software System

Applicant Thd Spa

K-Number K211623

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GEI 2021-06-24

Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand

Applicant ArthroCare Corporation

K-Number K210423

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PMN 2021-06-24

BioFire RP2.1/RP2.1plus Control Panel M441

Applicant Maine Molecular Quality Controls, Inc.

K-Number K202196

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LZA 2021-06-24

Powder Free Black Nitrile Examination Glove

Applicant Vietglove Corporation

K-Number K201428

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OCO 2021-06-24

TMJ Relax

Applicant Moonwalker Innovations, Inc.

K-Number K202523

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OLP 2021-06-24

Omnilux CLEAR

Applicant Globalmed Technologies

K-Number K210948

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GDW 2021-06-24

easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

Applicant Ezisurg Medical Co., Ltd.

K-Number K210909

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