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 2022-02-25

Pulse Oximeter

Applicant Shenzhen Mericonn Technology Co., Ltd.

K-Number K212300

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QQI 2022-02-25

FEops HEARTguide

Applicant Feops NV

K-Number K214066

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LNH 2022-02-25

MAGNETOM Vida with syngo MR XA50A

Applicant Siemens Medical Solutions USA, Inc.

K-Number K213693

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MRW 2022-02-25

Ion Facet Screw System

Applicant SurGenTec, LLC

K-Number K211855

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IZI 2022-02-25

Explorer Air II

Applicant Surgvision GmbH

K-Number K214097

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OLW 2022-02-25

Masimo SedLine Sedation Monitor and Accessories

Applicant Masimo Corporation

K-Number K203113

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GEX 2022-02-25

Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares

Applicant Canadian Pioneer Medical Technology Corporation

K-Number K211722

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HEB 2022-02-25

Cohitech Cottonlock Tampons with Reusable Applicator

Applicant Cotton High Tech S.L.

K-Number K220238

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FLL 2022-02-25

Ear Thermometer, Model ET005, ET008, ET009

Applicant Guangzhou Berrcom Medical Device Co., Ltd.

K-Number K213084

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MOL 2022-02-25

Okamoto 002 Lubricated Polyurethane Male Condom

Applicant Okamoto USA, Inc.

K-Number K203541

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GEI 2022-02-25

Cool-tip RF Ablation System E Series

Applicant Covidien, LLC

K-Number K203150

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IRP 2022-02-25

Normatec 3

Applicant NormaTec Industries, LP

K-Number K220217

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