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

FXX 2022-04-07

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

Applicant Gri-Alleset, Inc.

K-Number K210860

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DPS 2022-04-07

Electrocardiograph

Applicant Edan Instruments, Inc.

K-Number K212278

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NUJ 2022-04-07

Green OR Reprocessed Aquamantys Bipolar Sealer

Applicant Green Or, LLC

K-Number K211203

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NXC 2022-04-07

Invisalign System

Applicant Align Technology, Inc.

K-Number K220287

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LZO 2022-04-07

Corin MetaFix™ Hip Stem

Applicant Corin U.S.A. Limited

K-Number K212069

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FXX 2022-04-07

Dong Hai Xiang Surgical Mask

Applicant Taizhou Donghaixiang Protective Equipment Co., Ltd.

K-Number K212203

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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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