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

MBH 2025-10-24

Triathlon® Total Knee System - Triathlon® Gold Femoral Components

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K-Number K252044

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GJS 2025-10-24

CoaguChek XS Plus System

Applicant Roche Diagnostics

K-Number K253188

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NKB 2025-10-24

Fule Spinal Fixation System

Applicant Beijing Fule Science & Technology Development Co., Ltd.

K-Number K252730

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NKB 2025-10-24

CD Horizon™ Spinal System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K253335

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IYE 2025-10-24

AccuCheck

Applicant Manteia Technologies Co., Ltd.

K-Number K250696

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MAX 2025-10-24

Expandable Titanium PLIF/TLIF System

Applicant Spectrum Spine, Inc.

K-Number K253377

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QIH 2025-10-24

Syngo Carbon Clinicals (VA41)

Applicant Siemens Healthineers AG

K-Number K251059

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CFR 2025-10-24

Glucose2

Applicant Abbott Ireland

K-Number K252357

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NXC 2025-10-23

Invisalign® Palatal Expander System

Applicant Align Technology, Inc.

K-Number K252931

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GEX 2025-10-23

Picosecond Laser Device (PF131-BI)

Applicant Risu Medical Technology Co., Ltd.

K-Number K252345

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LZA 2025-10-23

Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

Applicant Hartalega NGC Sdn. Bhd.

K-Number K250861

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GEX 2025-10-23

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)

Applicant Zhengzhou PZ Laser Slim Technology Co., Ltd.

K-Number K252732

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