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

DRF 2026-01-08

Vision-MR™ Diagnostic Catheter

Applicant Imricor Medical Systems, Inc.

K-Number K252794

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LLZ 2026-01-08

View

Applicant GE Healthcare

K-Number K253639

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PHX 2026-01-08

Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)

Applicant Tornier, Inc.

K-Number K252788

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LLZ 2026-01-08

3DICOM MD Cloud

Applicant Singular Health Pty, Ltd.

K-Number K253784

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ODP 2026-01-08

Advantage-C™ Ti3D Cervical Interbody Fusion Device

Applicant Intelivation Technologies

K-Number K252711

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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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