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

IYE 2026-05-08

AerFrame Patient Immobilization System (AFPIS)

Applicant Stabilix, LLC

K-Number K260792

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HWC 2026-05-08

Arthrex Beaming System

Applicant Arthrex, Inc.

K-Number K254215

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LLZ 2026-05-08

HipGuide (V 1.0.0.0)

Applicant Orthopedic Driven Imaging, LLC

K-Number K260321

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GWG 2026-05-08

Hydro Irrigation System

Applicant Stryker Instruments

K-Number K253679

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HSB 2026-05-08

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

Applicant Orthofix Srl

K-Number K253991

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NXC 2026-05-08

Smylio Aligners

Applicant Smylio, Inc.

K-Number K260788

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OBE 2026-05-08

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

Applicant Zeus Scientific

K-Number K250814

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GXY 2026-05-08

Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

Applicant Elde Medikal Sanayi ve Ticaret Anonim Sirketi

K-Number K253237

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NFO 2026-05-08

DeepSkin (DEP100)

Applicant El Global Trade, Ltd.

K-Number K252621

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QPB 2026-05-08

AYON Body Contouring System™ (AYON SYSTEM)

Applicant Apyx Medical Corporation

K-Number K253396

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NEZ 2026-05-08

MiroCam® Capsule Endoscope System

Applicant Intromedic Co., Ltd.

K-Number K252617

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PNN 2026-05-08

LingOral Dental Design System

Applicant Hangzhou ChohoTech Co., Ltd.

K-Number K260419

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