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

ITI 2026-03-27

Electrically Powered Wheelchair (Model YC-01)

Applicant Yurob Rehabilitation Medical Co., Ltd.

K-Number K253980

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SDO 2026-03-27

ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)

Applicant Aneuvo

K-Number K252893

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JAK 2026-03-27

Spectral CT Verida Family

Applicant Philips Medical Systems Technologies , Ltd.

K-Number K253649

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ITI 2026-03-27

Electric wheelchair

Applicant Foshan Dahao Medical Technology Co., Ltd.

K-Number K253307

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LON 2026-03-26

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

Applicant BIOMERIEUX

K-Number K260281

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DYB 2026-03-26

Multiflex Steerable Sheath 17.5F

Applicant Vizaramed, Inc.

K-Number K260626

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QIH 2026-03-26

SwiftMR

Applicant Airs Medical, Inc.

K-Number K253775

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HAW 2026-03-26

Stealth AXiS Cranial clinical application

Applicant Medtronic Navigation, Inc.

K-Number K253379

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HBE 2026-03-26

Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)

Applicant Surgify Medical OY

K-Number K253627

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DXN 2026-03-26

Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)

Applicant Shenzhen Urion Technology Co., Ltd.

K-Number K260273

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OLO 2026-03-26

REAL INTELLIGENCE CORI

Applicant Blue Belt Technologies, Inc.

K-Number K260601

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QSM 2026-03-26

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

Applicant Restore Robotics

K-Number K252926

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