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

MYN 2023-09-13

Lung-CAD

Applicant Imagen Technologies, Inc.

K-Number K223811

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HTY 2023-09-13

OSSIOfiber® Cannulated Trimmable Fixation Nail

Applicant OSSIO , Ltd.

K-Number K230750

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OJQ 2023-09-13

AlloMap Heart Molecular Expression Testing

Applicant Caredx, Inc.

K-Number K221640

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GJT 2023-09-13

CRYOcheck Factor VIII Deficient Plasma with VWF

Applicant Precision Biologic, Inc.

K-Number K222831

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OBP 2023-09-13

Ultimate rTMS; Yingchi rTMS

Applicant Brain Ultimate, Inc.

K-Number K230735

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KPS 2023-09-12

Cartesion Prime (PCD-1000A/3) V10.15

Applicant Canon Medical Systems Corporation

K-Number K231748

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LQR 2023-09-12

Stone Extraction Baskets

Applicant Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K-Number K230598

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QHE 2023-09-12

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

Applicant Materialise NV

K-Number K231112

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HQF 2023-09-12

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

Applicant Meridian AG

K-Number K231011

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QTZ 2023-09-12

Ablation-fit

Applicant R.A.W. S.R.L

K-Number K222938

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KWQ 2023-09-12

Skyway Anterior Cervical Plate System

Applicant Kyocera Medical Technologies Inc. (KMTI)

K-Number K231766

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KPR 2023-09-12

Definium Pace Select

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K231892

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