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

NKG 2021-08-11

Z-LINKPC System

Applicant Zavation Medical Products, LLC

K-Number K211993

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JAK 2021-08-11

uCT ATLAS with uWS-CT-Dual Energy Analysis

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K203448

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NBW 2021-08-11

CONTOUR® NEXT ONE Blood Glucose Monitoring System

Applicant Ascensia Diabetes Care

K-Number K210687

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HGX 2021-08-11

Solo, Swing Maxi

Applicant Medela, LLC

K-Number K210759

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FXX 2021-08-11

Disposable Face Mask

Applicant Chaozhou Cecilia Technology Co., Ltd.

K-Number K203152

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QGN 2021-08-11

Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit

Applicant Cd Diagnostics, Inc.

K-Number K212204

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HSN 2021-08-11

QUANTUM® Patient Specific Instrumentation (PSI) System

Applicant In2bones Sas

K-Number K211883

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FLL 2021-08-11

Sensatronic Reusable Temperature Probes

Applicant Sensatronic GmbH

K-Number K203643

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FXX 2021-08-11

Surgical mask

Applicant Shandong Shengquan New Materials Co., Ltd.

K-Number K211552

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FXX 2021-08-11

Medical Face Mask

Applicant Shenzhen Lyttop Healthcare Limited

K-Number K211353

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QLG 2021-08-11

FreeStyle Libre 2 Flash Glucose Monitoring System

Applicant Abbott Diabetes Care, Inc.

K-Number K211102

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LZA 2021-08-11

Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate

Applicant Yty Industry (Manjung) Sdn Bhd

K-Number K202536

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