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

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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SHX 2026-05-08

Modius Spero

Applicant Neurovalens Limited

K-Number DEN250013

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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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NHA 2026-05-07

Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue

Applicant Institut Straumann AG

K-Number K260460

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PHX 2026-05-07

Veritas Reverse Total Shoulder System

Applicant Restor3D

K-Number K253992

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GEX 2026-05-07

CO2 Laser Machine (Monica-I,Monica-II)

Applicant Nanjing Bestview Laser S&T Co., Ltd.

K-Number K260974

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