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

NBW 2022-04-06

MTM301 Blood Glucose and Ketone Monitoring System

Applicant Apex BioTechnology Corp.

K-Number K202534

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FXX 2022-04-06

Disposable Medical Mask

Applicant Hubei Wanli Protective Products Co., Ltd.

K-Number K214085

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LZG 2022-04-06

Extended Reservoir

Applicant Medtronic Minimed, Inc.

K-Number K210714

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OBP 2022-04-06

ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System

Applicant Remed Co., Ltd.

K-Number K220625

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FRC 2022-04-06

3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader

Applicant 3M Company

K-Number K213809

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NTE 2022-04-06

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire

Applicant Cordis Corporation

K-Number K220654

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GEI 2022-04-06

Plasmage System

Applicant Brera Medical, Inc.

K-Number K202106

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MNR 2022-04-06

Onera Sleep Test System (Onera STS)

Applicant Onera B.V.

K-Number K210593

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LLZ 2022-04-06

ClariPulmo

Applicant Claripi, Inc.

K-Number K203783

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DZE 2022-04-06

NB 1 SA Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K213506

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QEW 2022-04-06

Prodigy Thrombectomy System

Applicant Truvic Medical, Inc.

K-Number K214114

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FDF 2022-04-06

Balloon Dilatation Catheter

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K213578

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