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

DSH 2021-02-28

QardioCore

Applicant Qardio, Inc.

K-Number K201644

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OLO 2021-02-26

Erisma LP Navigated Instruments

Applicant Clariance, Sas

K-Number K202956

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GEX 2021-02-26

Laser Treatment System, Model: NYX and Grace

Applicant Canadian Pioneer Medical Technology Corporation

K-Number K210033

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IYN 2021-02-26

SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K201968

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NVK 2021-02-26

Ultrafast, Ultrafast Plus, Ultrafast Lite

Applicant Dentlight, Inc.

K-Number K201387

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LLZ 2021-02-26

Cuptimize

Applicant Cuptimize, Inc.

K-Number K203651

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HGX 2021-02-26

imani i1

Applicant Imani Co.

K-Number K202045

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JOM 2021-02-26

ASI Plethysmogrpah Analyzer

Applicant Arterial Stiffness, Inc.

K-Number K200567

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IYN 2021-02-26

SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System

Applicant CHISON Medical Technologies Co., Ltd.

K-Number K201967

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OHT 2021-02-26

IPL Hair removal

Applicant Shenzhen Weikai Technology Co.,Ltd

K-Number K203510

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NXC 2021-02-26

AsoAligner

Applicant Aso International Manila, Inc.

K-Number K201104

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LYZ 2021-02-26

Disposable Vinyl Examination Gloves

Applicant Shandong Zhushi Pharmaceutical Group Co., Ltd.

K-Number K203439

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