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

DSB 2023-06-16

Zynex Monitoring System, Model CM-1600

Applicant Zynex Medical, Inc.

K-Number K223217

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QIH 2023-06-16

DeepCatch

Applicant Medical IP Co., Ltd.

K-Number K223556

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LJX 2023-06-16

Healgen URS Test Strips

Applicant Healgen Scientific,, LLC

K-Number K231045

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IOR 2023-06-16

Manual Wheelchair (A006)

Applicant Ningbo Shenyu Medical Equipment Co.,Ltd

K-Number K231110

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NGX 2023-06-16

Fitness Belt (Model: KLT-07)

Applicant Shenzhen Kelutongda Industrial Co., Ltd.

K-Number K231136

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QWX 2023-06-16

Neoasis

Applicant Invictus Medical, Inc.

K-Number DEN220048

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HQD 2023-06-16

Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens

Applicant Acuity Polymers, Inc.

K-Number K230965

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KTT 2023-06-16

Smart Correction System (HA Half Pins)

Applicant Wishbone Medical, Inc.

K-Number K231461

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DQA 2023-06-16

BabySat 3

Applicant Owlet Babycare, Inc.

K-Number K222597

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QIH 2023-06-16

IB Lab LAMA

Applicant Ib Lab GmbH

K-Number K223646

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CBK 2023-06-16

Mindray SV600 Ventilator, Mindray SV800 Ventilator

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K220107

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PIB 2023-06-16

EyeArt v2.2.0

Applicant Eyenuk, Inc.

K-Number K223357

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