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

MUH 2025-10-24

Cocoon Solo (DX-7020s)

Applicant Dexcowin Global, Inc.

K-Number K250687

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OWB 2025-10-24

Azurion R3.1

Applicant Philips Medical Systems B.V.

K-Number K251827

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QJP 2025-10-24

VersaD Delivery Catheter

Applicant Unity Medical, Inc.

K-Number K251372

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FTL 2025-10-24

Parietene™ Flat Sheet Mesh

Applicant Medtronic - Sofradim Production

K-Number K253125

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IZL 2025-10-24

Mobile X-ray unit (!M1)

Applicant Solutions For Tomorrow AB

K-Number K251710

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LHI 2025-10-24

Medline Bag Decanter

Applicant Medline Industries, LP

K-Number K250345

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LRK 2025-10-24

Hushd Pro Z-Link

Applicant Good Sleep CO Pte , Ltd.

K-Number K251784

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IRP 2025-10-24

Cryon-X Cold Compression

Applicant Jkh Health Co., Ltd.

K-Number K253150

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NKG 2025-10-24

Infinity™ OCT System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K253129

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DQK 2025-10-24

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub

Applicant Philips Medical Systems Nederland B.V.

K-Number K252645

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DQK 2025-10-24

CoroFlow Cardiovascular System

Applicant Coroventis Research AB

K-Number K252238

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FCG 2025-10-24

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

Applicant Olympus Medical Systems Corp.

K-Number K252646

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