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

FED 2021-07-30

Mini PCNL-System

Applicant Trokamed GmbH

K-Number K200770

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QLG 2021-07-30

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Applicant Abbott Diabetes Care, Inc.

K-Number K201761

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NRY 2021-07-30

EMBOTRAP III Revascularization Device

Applicant Neuravi, Ltd.

K-Number K211338

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LZA 2021-07-30

Disposable Nitrile Examination Gloves

Applicant Shenzhen Shiqiao Science and Technology Co., Ltd.

K-Number K211264

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KKX 2021-07-30

BeneHold Surgical Incise Drape with CHG antimicrobial

Applicant Avery Dennison Belgie Bvba

K-Number K202208

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PCC 2021-07-30

Elexir

Applicant Nu Eyne Co., Ltd.

K-Number K211380

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QEW 2021-07-30

Pounce Thrombectomy System

Applicant Surmodics,Inc.

K-Number K211492

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MUJ 2021-07-30

syngo.via RT Image Suite

Applicant Siemens Medical Solutions USA, Inc.

K-Number K211379

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HRS 2021-07-30

Summit Patella Plating System

Applicant Endeavor Orthopaedics, LLC

K-Number K203408

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FXX 2021-07-30

MEO Med Disposable Medical Face Mask

Applicant Fujian Meo Medical Technology Limited

K-Number K210870

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LZA 2021-07-30

Disposable Nitrile Medical Examination Glove

Applicant Jiangsu Cureguard Glove Co., Ltd.

K-Number K210691

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MQB 2021-07-30

DX-D Imaging Package with XD Detectors

Applicant Agfa N.V.

K-Number K211790

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