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

DQX 2021-02-18

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire

Applicant Beijing Bywave Sensing Medical Technology Co., Ltd.

K-Number K201720

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NEU 2021-02-18

Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape

Applicant Somatex Medical Technologies GmbH

K-Number K201863

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OAS 2021-02-18

Green X 18(Model : PHT-75CHS)

Applicant VATECH Co., Ltd.

K-Number K210329

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OAS 2021-02-18

3D Accuitomo 150N

Applicant J. Morita USA, Inc.

K-Number K201378

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PSN 2021-02-18

Demetra Analytics Toolkit

Applicant Barco N.V.

K-Number K201408

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NKB 2021-02-18

4CIS SARA Spine System, 4CIS VERTU Spine System

Applicant Solco Biomedical Company India Private Limited

K-Number K202498

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PYT 2021-02-18

Clue Birth Control

Applicant Biowink GmbH

K-Number K193330

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LLZ 2021-02-18

PhantomMSK Hip

Applicant OrthoGrid Systems, Inc.

K-Number K210136

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FXX 2021-02-18

Surgical Face Mask (non-sterile)

Applicant Nantong Taiweishi Medical Technology Co., Ltd.

K-Number K203426

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FLL 2021-02-18

Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60

Applicant Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

K-Number K202687

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EOX 2021-02-18

EsoCheck Cell Collection Device

Applicant Lucid Diagnostics, Inc.

K-Number K210137

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DZE 2021-02-17

s-Clean SQ-SL Implant System Regular

Applicant Dentis Co., Ltd.

K-Number K210132

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