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

NKG 2025-10-24

Infinity OCT System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K253129

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DQK 2025-10-24

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub

Applicant Philips Medical Systems Nederland B.V.

K-Number K252645

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DQK 2025-10-24

CoroFlow Cardiovascular System

Applicant Coroventis Research AB

K-Number K252238

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FCG 2025-10-24

Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)

Applicant Olympus Medical Systems Corp.

K-Number K252646

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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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