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

JAK 2022-09-12

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

Applicant Canon Medical Systems Corporation

K-Number K220986

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OUR 2022-09-12

Integrity-SI Fusion System

Applicant OsteoCentric Technologies

K-Number K222512

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KLE 2022-09-12

Phosphoric Acid Etching Gel

Applicant Rizhao Huge Biomaterials Company, Ltd.

K-Number K221450

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IYN 2022-09-12

KOLO Evolution XHD Series Ultrasound Diagnostic System

Applicant Kolo Medical (Suzhou) Co., Ltd.

K-Number K221568

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DQY 2022-09-12

SOFIA 88 Catheter

Applicant MicroVention, Inc.

K-Number K214024

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QAS 2022-09-12

Rapid ICH

Applicant Ischemaview, Inc.

K-Number K221456

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FLL 2022-09-12

Infrared Forehead Thermometer

Applicant Qingdao Yasee Medical Device Co., Ltd.

K-Number K220084

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LZA 2022-09-09

Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)

Applicant Careglove Global Sdn. Bhd.

K-Number K220859

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FXX 2022-09-09

PointCore Surgical Mask

Applicant Pointcore, Inc.

K-Number K220944

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HQC 2022-09-09

MICOR Lens Fragmentation System

Applicant Carl Zeiss Meditec Cataract Technology, Inc.

K-Number K214028

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EBF 2022-09-09

AMBARINO High-Class

Applicant Creamed GmbH & Co. Produktions- Und Handels KG

K-Number K222723

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GXY 2022-09-09

Dexus Prosthetics System (Model: MSL1, MSR1)

Applicant Zhejiang Qiangnao Technology Co.,Ltd

K-Number K220002

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