Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

NDN 2026-01-28

XeliteMed SuperM-Fix Spinal Bone Cement

Applicant Xelite Biomed , Ltd.

K-Number K251896

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QAS 2026-01-27

BriefCase-Triage

Applicant Aidoc Medical , Ltd.

K-Number K251195

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HCG 2026-01-27

Optima Coil System (OptiOne Coil System)

Applicant Balt USA, LLC

K-Number K254221

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GEI 2026-01-27

Reusable 3 Button Fingerswitch Wand

Applicant Soniquence, LLC

K-Number K254220

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GEI 2026-01-27

InbellaIgnite RF System

Applicant Inbella Medical, Inc.

K-Number K251435

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LOL 2026-01-27

Access anti-HAV IgM

Applicant Beckman Coulter, Inc.

K-Number K251995

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LNH 2026-01-26

Ascent3T Neonatal Magnetic Resonance Imaging System

Applicant Eyas Medical Imaging, Inc.

K-Number K253499

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DPS 2026-01-26

MAC 7 Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K251670

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KDI 2026-01-26

Tablo Hemodialysis System (PN-0008000, PN-0006000U)

Applicant Outset Medical, Inc.

K-Number K253412

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GEX 2026-01-24

Vydence Family of Lasers

Applicant Vydence Medical Industria E Commercio Ltda

K-Number K252753

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GEX 2026-01-24

Holmium Laser Therapeutic Apparatus (HZ-40)

Applicant Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

K-Number K253633

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OLO 2026-01-23

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

Applicant Point Robotics MedTech, Inc.

K-Number K252755

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