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

KWQ 2020-08-25

Cervical Plate System

Applicant Eminent Spine, LLC

K-Number K201979

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FMI 2020-08-25

Injection Pen Needle

Applicant Gangan Medical Technology Jiangsu Co., Ltd.

K-Number K192464

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LZA 2020-08-25

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K201772

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FLL 2020-08-25

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K193338

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MQL 2020-08-25

iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA

Applicant Kitazato Corporation

K-Number K193522

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EFA 2020-08-25

Dental Handpiece

Applicant Micro-Nx Co., Ltd.

K-Number K192809

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ONN 2020-08-25

VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder

Applicant Orthosensor, Inc.

K-Number K200587

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MNR 2020-08-24

MATRx plus

Applicant Zephyr Sleep Technologies

K-Number K200695

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HIR 2020-08-24

Intimate Rose Kegel Exercise System

Applicant Plus EV Holdings Dba Intimate Rose

K-Number K193364

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NBC 2020-08-24

ST AIA-PACK BNP

Applicant Fujirebio Diagnostics,Inc.

K-Number K192380

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KTT 2020-08-24

Dynex Ring Fixation System, Diametrix Ring Fixation System

Applicant Vilex, LLC

K-Number K202054

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OCC 2020-08-22

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

Applicant Diasorin Molecular, LLC

K-Number K201505

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