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

DZI 2024-07-18

Surgical Drive System (Model: ES70, ES90, E8)

Applicant Guangdong Jinme Medical Technology Co., Ltd.

K-Number K240340

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JTN 2024-07-18

HardyDisk AST Cefiderocol 30µg (FDC30)

Applicant Hardy Diagnostics

K-Number K241060

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FZP 2024-07-18

SOLID CLIP™ Single Use Clip Applier

Applicant Medscope Biotech Co., Ltd.

K-Number K221495

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QOF 2024-07-18

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Applicant Hologic, Inc.

K-Number K241240

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ITI 2024-07-18

Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)

Applicant Suzhou Master Machinery Manufacturing Co.,Ltd

K-Number K241463

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QEW 2024-07-18

ICHOR 7F Embolectomy System (ICH-7F)

Applicant Ichor

K-Number K233917

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OVD 2024-07-18

Juliet® Ti LL Lumbar Interbody Device

Applicant Spineart SA

K-Number K241321

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LLZ 2024-07-18

vRad Viewer

Applicant Virtual Radiologic Corporation

K-Number K241879

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DXO 2024-07-17

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_

Applicant Acist Medical Systems, Inc.

K-Number K233904

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KNF 2024-07-17

Sonata Transcervical Fibroid Ablation System 2.2

Applicant Gynesonics, Inc.

K-Number K240503

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QBS 2024-07-17

Rayvolve

Applicant Azmed Sas

K-Number K240845

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OBO 2024-07-17

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System

Applicant Topcon Corporation

K-Number K241081

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