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

MUH 2023-09-13

GenX-CR

Applicant Genoray Co., Ltd.

K-Number K232158

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QJP 2023-09-13

NG Delivery Catheter

Applicant Balt USA, LLC

K-Number K230609

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FLE 2023-09-13

AMSCO 600 Steam Sterilizer

Applicant Steris

K-Number K232485

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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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QXV 2023-09-13

ensoETM

Applicant Advanced Cooling Therapy, Inc. D/B/A Attune Medical

K-Number DEN230021

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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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