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

SBH 2026-06-12

Stelo Glucose Biosensor System

Applicant Dexcom, Inc.

K-Number K260935

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HGX 2026-06-12

Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)

Applicant Polybell (Guangzhou) Limited

K-Number K260346

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HRS 2026-06-12

Exalta Proximal Tibia Plating System

Applicant Tyber Medical, LLC

K-Number K261207

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ONF 2026-06-12

Intense Pulsed Light Therapy Device

Applicant Sanhe LEFIS Electronics Co., Ltd.

K-Number K261204

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LBH 2026-06-11

Fluoride Varnish (Type A,Type C)

Applicant Nagy Oral Technology Qinhuangdao Co., Ltd.

K-Number K253052

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NHA 2026-06-11

Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)

Applicant Smart Denture Conversions, LLC

K-Number K254145

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LXB 2026-06-11

Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

Applicant Shenzhen Magnet Technology Co., Ltd.

K-Number K261256

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MRW 2026-06-11

Ion-L

Applicant SurGenTec, LLC

K-Number K261209

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LHN 2026-06-11

PROBEAT-CR

Applicant Hitachi High-Tech Corp.

K-Number K260174

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QIH 2026-06-11

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Applicant Mighty Oak Medical

K-Number K260322

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SEM 2026-06-11

UNEEG EpiSight System

Applicant Uneeg Medical A/S

K-Number K253607

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MMI 2026-06-11

i-STAT hs-TnI cartridge with the i-STAT Alinity System

Applicant Abbott Point of Care, Inc.

K-Number K253051

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