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

DQY 2023-10-13

Paragon 8F Balloon Guide Catheter

Applicant Wallaby Medical

K-Number K232437

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BTT 2023-10-13

BONHAWA Respiratory Humidifier

Applicant Telesair, Inc.

K-Number K223863

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GEI 2023-10-13

The Evolve System with the Transform Applicator

Applicant InMode , Ltd.

K-Number K231495

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LCX 2023-10-13

Macro & Micro-Test HCG Pregnancy Test Midstream

Applicant Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

K-Number K230741

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DZE 2023-10-13

MRI compatibility for existing BioHorizons dental implants and abutments

Applicant BioHorizons Implant Systems, Inc.

K-Number K223697

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MAX 2023-10-13

Calibrate CCX Interbody System

Applicant Alphatec Spine, Inc.

K-Number K232504

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NKB 2023-10-13

VyLink™ Spinal Screw System

Applicant Vy Spine, LLC

K-Number K231744

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LCJ 2023-10-13

Motiva Flora SmoothSilk Tissue Expander

Applicant Motiva USA, LLC

K-Number K211676

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PLR 2023-10-13

RIGEL™ 3DR Anterior Cervical Corpectomy System

Applicant MiRus, LLC

K-Number K232481

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PNN 2023-10-13

Titan Dental Design

Applicant Clearadvance, LLC

K-Number K232429

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GWG 2023-10-13

Neuroblade System

Applicant Clearmind Biomedical

K-Number K230125

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JAK 2023-10-13

SpotLight/SpotLight Duo (with DLIR option)

Applicant Arineta , Ltd.

K-Number K230370

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