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

NHA 2024-07-25

s-Clean ScanHealing Abutment

Applicant Dentis Co., Ltd.

K-Number K241063

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OLO 2024-07-24

POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)

Applicant Point Robotics MedTech, Inc.

K-Number K241130

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GCJ 2024-07-24

P-SCOPE

Applicant Oui Medical, Inc.

K-Number K241502

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EMA 2024-07-24

Insure® Universal; Insure® Universal Automix

Applicant Cosmedent, Inc.

K-Number K240714

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GEI 2024-07-24

InMode RF System

Applicant InMode , Ltd.

K-Number K240780

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GEH 2024-07-24

C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)

Applicant Pentax of America, Inc.

K-Number K240457

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MUI 2024-07-24

Non-Sterile Ultrasound Transmission Gels

Applicant Hony Medical Co., Ltd.

K-Number K241789

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NPM 2024-07-24

THE Graft Collagen

Applicant Purgo Biologics, Inc.

K-Number K230305

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QNP 2024-07-24

CADDIE

Applicant Odin Medical Limited

K-Number K240044

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KWQ 2024-07-24

FlexWing Anterior Cervical Plate System

Applicant Jeil Medical Corporation

K-Number K231251

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IYE 2024-07-24

ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface

Applicant Brainlab AG

K-Number K240431

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MZP 2024-07-24

Aptima HCV Quant Dx Assay

Applicant Hologic, Inc.

K-Number K233352

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