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

JWH 2022-10-06

b-ONER MOBIO Total Knee System

Applicant B-One Ortho, Corp.

K-Number K222431

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DQO 2022-10-06

NuCath Wedge Pressure Catheter

Applicant Pfm Medical, Inc.

K-Number K213666

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QDQ 2022-10-06

Genius AI Detection 2.0

Applicant Hologic, Inc.

K-Number K221449

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HKY 2022-10-06

iCare IC200

Applicant Icare Finland OY

K-Number K220852

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GEI 2022-10-05

Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP

Applicant Led Spa

K-Number K220138

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MRW 2022-10-05

FaSet Fixation System

Applicant Dio Medical Corporation

K-Number K222515

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NXC 2022-10-05

ClearCorrect System

Applicant Clearcorrect, LLC

K-Number K220140

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LON 2022-10-05

Colibrí System

Applicant Copan Wasp Srl

K-Number K220546

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MAI 2022-10-05

Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II

Applicant Arthrex, Inc.

K-Number K221128

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FGB 2022-10-05

Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K222737

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BXQ 2022-10-05

VISIONAIR

Applicant Pacificmd Biotech, LLC

K-Number K221892

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LYX 2022-10-05

Cornisol

Applicant Aurolab

K-Number K221759

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