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

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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EIH 2021-06-24

Perfit FS Dental Zirconia Fully Sintered Block

Applicant Vatech Acucera, Inc.

K-Number K203590

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IYN 2021-06-24

RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K210959

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KGO 2021-06-24

ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs

Applicant Careplus (M) Sdn Bhd

K-Number K210656

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GCJ 2021-06-24

Cor-Knot Micro

Applicant Lsi Solutions, Inc.

K-Number K202551

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OWB 2021-06-24

Virtual C DRF Digital Imaging System

Applicant Portavision Medical, LLC

K-Number K211191

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MAX 2021-06-24

LABYRINTH

Applicant Zavation Medical Products, LLC

K-Number K211306

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PYT 2021-06-24

Natural Cycles

Applicant Natural Cycles Nordic AB

K-Number K202897

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