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

OBJ 2026-09-10

ACUNAV Luxera 4D ICE Catheter

Applicant Siemens Medical Solutions USA, Inc.

K-Number K261696

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QIH 2026-09-10

4DM

Applicant INVIA, LLC

K-Number K260879

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DRS 2026-09-10

TruPress

Applicant Procerus Enterprises

K-Number K254074

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EBF 2026-09-10

Cerasmart Forte

Applicant GC America, Inc.

K-Number K262202

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NFT 2026-09-10

BioTeke® Multi-Drug Urine Test Cup

Applicant Bioteke Corporation (Wuxi) Co., Ltd.

K-Number K261409

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GEX 2026-09-10

Diode Laser Therapy System

Applicant Sanhe LEFIS Electronics Co., Ltd.

K-Number K261562

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DXN 2026-09-10

Upper Arm Blood pressure monitor (BP7155D)

Applicant OMRON Healthcare, Inc.

K-Number K261929

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LJH 2026-09-10

Irrigation/Urology Sets

Applicant B.Braun Medical, Inc.

K-Number K254111

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QIH 2026-09-10

Quicktome Software Suite

Applicant Omniscient Neurotechnology Pty, Ltd.

K-Number K261795

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NAD 2026-09-10

LT Antibacterial Foam with Silver Dressing

Applicant Zhejiang Longterm Medical Technology Co., Ltd.

K-Number K254246

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SJH 2026-09-10

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

Applicant Lakong Medical Devices Co., Ltd.

K-Number K254009

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GEX 2026-09-10

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)

Applicant Wuhan Pioon Technology Co., Ltd.

K-Number K262426

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