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

DQA 2020-03-13

Disposable SpO2 Sensor

Applicant Shenzhen Changke Connect Electronics Co., Ltd.

K-Number K200069

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LYR 2020-03-13

Curian HpSA, Curian Analyzer

Applicant Meridian Bioscience, Inc.

K-Number K192817

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LZA 2020-03-13

Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Applicant O&M Haylard, Inc.

K-Number K192241

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OAS 2020-03-13

CS 9600

Applicant Trophy

K-Number K200183

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DWF 2020-03-13

Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula

Applicant Edwards Lifesciences, LLC

K-Number K200358

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LLZ 2020-03-13

EzOrtho

Applicant Ewoosoft Co., Ltd.

K-Number K192888

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KNT 2020-03-13

Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches

Applicant Prosys International, Ltd.

K-Number K193325

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CGA 2020-03-13

Stat Profile Prime Plus Analyzer System

Applicant Nova Biomedical Corporation

K-Number K200349

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NXC 2020-03-12

NEOLab Clear Aligners

Applicant New England Ortho Lab, Inc.

K-Number K192338

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IYE 2020-03-12

RefleXion Medical Radiotherapy System

Applicant Reflexion Medical, Inc.

K-Number K190978

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MRZ 2020-03-12

SpaceStation MRI

Applicant B. Braun Melsugen AG

K-Number K191910

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MBI 2020-03-12

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K200341

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