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

IYN 2022-10-11

SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25)

Applicant Bionet Co., Ltd.

K-Number K220169

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GCJ 2022-10-11

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control

Applicant Stryker Endoscopy

K-Number K222079

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OHT 2022-10-11

IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439

Applicant Hunan Guangye Biotechnology Co., Ltd.

K-Number K222432

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HQF 2022-10-11

ECHO Photocoagulator

Applicant Norlase

K-Number K222157

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QJP 2022-10-11

Branchor Balloon Guide Catheter

Applicant Asahi Intecc Co., Ltd.

K-Number K221951

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EBF 2022-10-11

Renamel® Microhybrid ;Renamel® Flowable Microhybrid

Applicant Cosmedent, Inc.

K-Number K222435

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FMF 2022-10-11

Sol-M Luer Lock Syringe

Applicant Sol-Millennium Medical, Inc.

K-Number K222744

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LYZ 2022-10-08

Disposable Vinyl Examination Gloves

Applicant Jiangxi Handspro Products Solutions Co., Ltd.

K-Number K223008

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LZA 2022-10-07

Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs

Applicant Guangdong Kingfa Sci. & Tech.Co., Ltd.

K-Number K222714

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NGX 2022-10-07

Miha Bodytec II

Applicant Miha Bodytec GmbH

K-Number K221498

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OAT 2022-10-07

Mico One Orthodontic Screw

Applicant Ze Fang Technology Co., Ltd.

K-Number K202163

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OKJ 2022-10-07

Cold Sore Device (Model: QPZ-01)

Applicant Light Tree Ventures Europe B.V.

K-Number K222205

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