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

OHT 2026-08-10

Hair Removal Device (R3C16-G Pro, R3C16-V Pro)

Applicant Shenzhen Jianchao Intelligent Technology Co., Ltd.

K-Number K261705

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PKL 2026-08-10

Hemoclip (511 series, 543 series)

Applicant Hangzhou AGS MedTech Co., Ltd.

K-Number K254069

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QIH 2026-08-10

Prostate Core

Applicant Lucida Medical, Ltd.

K-Number K253794

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HGM 2026-08-10

Novii+ Wireless Patch System

Applicant Datex Ohmeda, Inc.

K-Number K254036

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MPA 2026-08-10

Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)

Applicant Nova Eye, Inc.

K-Number K253468

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FMI 2026-08-10

Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)

Applicant Hh Global Technology, Inc.

K-Number K262427

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INI 2026-08-10

Mobility Scooter (W3465, W3902 (S50 Carbon))

Applicant Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

K-Number K260094

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MEH 2026-08-10

Icona Hip Stem

Applicant Corin, Ltd.

K-Number K261576

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FOZ 2026-08-10

Unimpregnated Central Venous Catheter

Applicant Spectrum Vascular

K-Number K260165

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FGB 2026-08-07

Zamenix™ P

Applicant Roen Surgical, Inc.

K-Number K253505

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FDS 2026-08-07

Intuitive Endoluminal Gastrointestinal System (IG1000)

Applicant Intuitive Surgical, Inc.

K-Number K253702

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EIA 2026-08-07

Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

Applicant Lakong Medical Devices Co., Ltd.

K-Number K251544

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