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

NFJ 2021-06-15

CellChek 20 rc

Applicant Konan Medical, Inc.

K-Number K203244

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FXX 2021-06-15

Amerishield Surgical Mask

Applicant Premiumestore, LLC

K-Number K211520

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FFK 2021-06-14

URO-TOUCH 9 French Probe

Applicant Northgate Technologies, Inc.

K-Number K202813

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NUC 2021-06-14

Coconu Water Based Personal Lubricant

Applicant Coconu, LLC

K-Number K210814

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HKY 2021-06-14

CATS®-D Tonometer Prism

Applicant Cats Tonometer, LLC

K-Number K203850

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MCW 2021-06-14

2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System

Applicant Volcano Atheromed, Inc.

K-Number K211518

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CAF 2021-06-14

Corrugated tube with mouthpiece accessory

Applicant Trudell Medical International

K-Number K203400

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FXX 2021-06-14

Surgical Face Mask

Applicant Shandong Haidike Medical Products Co., Ltd.

K-Number K210518

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EBG 2021-06-14

E-Temp

Applicant Envisiontec GmbH

K-Number K211101

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IOR 2021-06-14

Manual Wheelchair (Model W28)

Applicant Jiangsu Jumao X-Care Medical Equipment Co., Ltd.

K-Number K200466

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LON 2021-06-14

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)

Applicant bioMerieux, Inc.

K-Number K211136

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CAF 2021-06-14

Ultrasonic Mesh Nebulizer

Applicant Shenzhen Ivankaca Technology Co., Ltd.

K-Number K201397

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