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

IZL 2021-01-06

SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System

Applicant Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

K-Number K202350

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FER 2021-01-06

Applied Medical Anoscope

Applicant Applied Medical Resources

K-Number K200021

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FYA 2021-01-06

Medical Surgical Gowns

Applicant Beijing Biosis Healing Biolog Ical Technology Co., Ltd.

K-Number K202844

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ODC 2021-01-06

Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B

Applicant Wilson Instruments (Sha) Co., Ltd.

K-Number K200769

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NXC 2021-01-06

NEOLab Clear Aligners

Applicant New England Ortho Lab, Inc.

K-Number K203339

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HWC 2021-01-05

Fixone Biocomposite Interference Screw

Applicant Aju Pharm Co., Ltd.

K-Number K193497

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NEY 2021-01-05

ABI Instrument, Creo Electrosurgical System

Applicant Creo Medical, Ltd.

K-Number K200298

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DPW 2021-01-05

Bidop 7

Applicant Koven Technology, Inc.

K-Number K201114

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FLL 2021-01-05

Non-contact Infrared Body Thermometer, model:HTD8823US

Applicant Hetaida Technology Co., Ltd.

K-Number K200159

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KTT 2021-01-05

Bfix Orthopedic External Fixator Systems

Applicant Aike (Shanghai) Medical Instrument Co., Ltd.

K-Number K200491

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FPA 2021-01-05

NeutrArt

Applicant Asset Medikal Tasarim As.

K-Number K201872

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FMF 2021-01-05

Insulin Syringe

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K193273

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