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

KNG 2026-01-08

Fetal Doppler U8-25, U9-25

Applicant Zhongshan Xiaolan Town Senlan Electronic Factory

K-Number K252669

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NDC 2026-01-08

MiniMed Go App

Applicant Medtronic Minimed

K-Number K253512

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DZE 2026-01-08

ZENEX Implant System_R-System

Applicant Izenimplant Co., Ltd.

K-Number K252585

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MAX 2026-01-08

Titanium Interbody System

Applicant Spine Innovation, LLC

K-Number K253266

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FLL 2026-01-08

Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

Applicant Shenzhen Med-Link Electronics Tech Co., Ltd.

K-Number K251160

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PPT 2026-01-07

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models

Applicant Materialise NV

K-Number K253308

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DQA 2026-01-07

Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)

Applicant Shenzhen Best Electronics Co., Ltd.

K-Number K253109

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BZD 2026-01-07

DeltaWave Nasal Pillow System

Applicant RemSleep Holdings, Inc.

K-Number K253939

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NXC 2026-01-07

Clear Aligner (SCF-3348)

Applicant Beame Medical Technology (Shenzhen) Limited

K-Number K251454

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IYN 2026-01-07

LOGIQ Fortis

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K253366

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NKB 2026-01-07

CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K253941

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PNE 2026-01-07

Reprocessed Agilis NxT Steerable Introducer

Applicant Innovative Health

K-Number K250305

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