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

MBI 2024-11-26

OsseoFit Interfacing Anchor; OsseoFit Bone Tunnel Construct

Applicant Riverpoint Medical, LLC

K-Number K242494

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DXN 2024-11-26

Arm Blood Pressure Monitor (model: BPM-A7VL)

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K-Number K243118

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NAY 2024-11-26

da Vinci SP Surgical System (SP1098)

Applicant Intuitive Surgical, Inc.

K-Number K242318

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HRS 2024-11-26

TriMed Posterior Malleolus Fixation System

Applicant TriMed, Inc.

K-Number K243050

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DXF 2024-11-26

Cross Wise™ Multi-Use RF Adapter Cable

Applicant Circa Scientific, Inc.

K-Number K243193

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EZD 2024-11-26

SureCath Set

Applicant Coloplast Corp.

K-Number K242049

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NKB 2024-11-26

4CIS® Chiron Spinal Fixation System

Applicant Solco Biomedical Co., Ltd.

K-Number K231655

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EBG 2024-11-26

PrimmaArt

Applicant Dentscare Ltda

K-Number K231859

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GEI 2024-11-26

Cellinew

Applicant VIOL Co., Ltd.

K-Number K240897

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LNH 2024-11-26

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)

Applicant Asg Superconductors S.P.A.

K-Number K242258

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JAQ 2024-11-26

Intraluminal Applicator Set

Applicant Varian Medical Systems

K-Number K242961

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OWY 2024-11-26

REGENETEN™ Bioinductive Implant

Applicant Smith & Nephew Inc., Endoscopy Div.

K-Number K242631

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