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

PNN 2026-03-04

SureSmile Software

Applicant Dentsply Sirona, Inc.

K-Number K253565

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DZE 2026-03-04

Dentis SQ-SL AXEL Fixture

Applicant Dentis Co., Ltd.

K-Number K253493

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FTC 2026-03-04

Klär Lite (RCW-KL1000)

Applicant Radcliffe Watts, LLC

K-Number K253871

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NUH 2026-03-04

TENS/EMS device (GUSE01)

Applicant Globalcare Medical Technology Co., Ltd.

K-Number K253896

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OLP 2026-03-04

LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K253878

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HSB 2026-03-04

Active Intramedullary (AIM) Tibial Nail System

Applicant Satori Orthopaedics, Inc.

K-Number K252025

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QAS 2026-03-03

Annalise Enterprise

Applicant Harrison-AI Medical Pty, Ltd.

K-Number K253818

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HRS 2026-03-03

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

Applicant Arthrex, Inc.

K-Number K260353

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GEX 2026-03-03

CO2 Laser Treatment Machine (CFR3M1)

Applicant Haidari Beauty Technology (Beijing) Co., Ltd.

K-Number K253920

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FXX 2026-03-03

Surgical Face Mask (Ear mount)

Applicant Zhejiang Hangkang Medical Equipment Co., Ltd.

K-Number K252534

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LRK 2026-03-03

Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)

Applicant Ram.Shaw Pte. , Ltd.

K-Number K253845

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EBF 2026-03-03

ZAFIRA®

Applicant New Stetic, SA

K-Number K254245

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