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

KPS 2022-05-31

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K213731

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LZA 2022-05-31

Disposable Powder Free Polyethylene Examination Gloves

Applicant Mastermax Plastic (Huizhou), Ltd.

K-Number K212699

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QJP 2022-05-31

Distal Access Catheter

Applicant Guangzhou Easycess Medical Co.,Ltd

K-Number K213065

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DYB 2022-05-31

Liverty TIPS Access Set

Applicant Bard Peripheral Vascular, Inc.

K-Number K221440

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CDQ 2022-05-31

Urea Nitrogen2

Applicant Abbott Ireland Diagnostics Division

K-Number K203771

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QAS 2022-05-31

Rapid LVO

Applicant Ischemaview, Inc.

K-Number K221248

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OMP 2022-05-31

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

Applicant Zhejiang Longterm Medical Technology Co., Ltd.

K-Number K211571

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DXN 2022-05-31

Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)

Applicant Shenzhen Finicare Co., Ltd.

K-Number K220113

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KGN 2022-05-31

Fibrillar Collagen Wound Dressing

Applicant Collagen Matrix, Inc.

K-Number K213341

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DQD 2022-05-31

eMurmur Heart AI

Applicant Csd Labs GmbH

K-Number K220766

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LRK 2022-05-31

Respire Clear

Applicant Respire Medical, LLC

K-Number K214096

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LZA 2022-05-28

Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution

Applicant Shen Wei USA, Inc.

K-Number K213141

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