Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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

QIH 2022-09-27

NS-HGlio

Applicant Neosoma, Inc.

K-Number K221738

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GEI 2022-09-27

MTX-C1

Applicant Ilooda Co,., Ltd.

K-Number K212561

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OWB 2022-09-27

XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3

Applicant Canon Medical Systems Corporation

K-Number K220342

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IYN 2022-09-27

5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)

Applicant Philips Ultrasound, LLC

K-Number K222648

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EBW 2022-09-27

Dental Implantation Systems, Dental Electrical Motors

Applicant Foshan Coxo Medical Instrument Co., Ltd.

K-Number K220831

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HRS 2022-09-27

Medline UNITE® Medial Malleolus Peg Plate System

Applicant Medline Industries, LP

K-Number K221360

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MQB 2022-09-27

Digital Radiography CXDI-CS01

Applicant Canon, Inc.

K-Number K222661

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FLL 2022-09-27

Infrared thermometer

Applicant Shenzhen Yolanda Technology Co., Ltd.

K-Number K221211

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OCX 2022-09-27

Clean Connecting Tube

Applicant Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K-Number K220785

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FPA 2022-09-26

Flowart

Applicant Asset Medikal Tasarim As.

K-Number K221473

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DXH 2022-09-26

QT ECG

Applicant QT Medical, Inc.

K-Number K220795

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PBX 2022-09-26

Palm NRG cellulite body device (model: Palm NRG body device)

Applicant Heat IN A Click, LLC

K-Number K214015

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