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

GXQ 2025-11-18

Collagen Dura Regeneration Membrane - Repair

Applicant Collagen Matrix, Inc.

K-Number K251191

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IZQ 2025-11-18

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)

Applicant Ulrich GmbH & Co. KG

K-Number K252281

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QRX 2025-11-18

Dexcom Smart Basal

Applicant Dexcom, Inc.

K-Number K252818

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NKB 2025-11-18

Universal Spinal System

Applicant Double Medical Technology, Inc.

K-Number K252729

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FGB 2025-11-18

Miniature Telescope for Urology (27033AA)

Applicant Karl Storz SE & CO. KG

K-Number K253411

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HIS 2025-11-18

LifeStyles® HydraFeel Natural Rubber Latex Condom

Applicant Suretex Limited

K-Number K252521

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HRS 2025-11-18

ToeJack MIS Bunion System

Applicant Nvision Biomedical Technologies, Inc.

K-Number K253423

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DQA 2025-11-18

Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)

Applicant Unimed Medical Supplies, Inc.

K-Number K251695

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DQA 2025-11-18

Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)

Applicant Unimed Medical Supplies, Inc.

K-Number K251693

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NHA 2025-11-18

Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems

Applicant Prismatik Dentalcraft, Inc.

K-Number K252582

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NFT 2025-11-18

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx

Applicant Guangzhou Wondfo Biotech Co., Ltd.

K-Number K252550

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DXH 2025-11-18

Hexoskin Medical System (7100-00016)

Applicant Carre Technologies, Inc.

K-Number K243981

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