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

NBW 2021-09-01

EASYMAX Tag Self-Monitoring Blood Glucose System

Applicant Eps Bio Technology Corp.

K-Number K201258

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DQA 2021-09-01

Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)

Applicant Leadtek Research, Inc.

K-Number K210032

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GEX 2021-09-01

Leonardo Mini Blue

Applicant Ceramoptec GmbH

K-Number K210951

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IRP 2021-09-01

SP-1000, SP-2000

Applicant Daesung Maref Co., Ltd.

K-Number K202395

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KWQ 2021-09-01

Admiral ACP System

Applicant SeaSpine Orthopedics Corporation

K-Number K212139

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LZA 2021-09-01

Disposable Medical Nitrile Gloves

Applicant Changzhou Yihua Sanitation Material Co., Ltd.

K-Number K211673

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GZL 2021-09-01

Evo sEEG System

Applicant Neuroone Medical Technologies Corp.

K-Number K211367

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OHT 2021-09-01

IPL Hair Removal

Applicant Shenzhen Qiaochengli Technology Co., Ltd.

K-Number K211174

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MAX 2021-09-01

EndoLIF Delta-Cage and DoubleWedge-Cage

Applicant Joimax GmbH

K-Number K203014

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JCT 2021-09-01

Tracheal Stent System

Applicant Micro-Tech (Nanjing) Co., Ltd.

K-Number K202204

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MVV 2021-09-01

Bonine Acupressure Bands

Applicant Wellspring Pharmaceutical Corporation

K-Number K211823

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MRG 2021-09-01

Elecsys Vitamin D total III

Applicant Roche Diagnostics

K-Number K210901

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