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

QYE 2025-07-15

Tempus ECG-Low EF

Applicant Tempus AI, Inc.

K-Number K250119

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QUW 2025-07-15

Jewel Soft Tissue Reinforcement Device (102-6005)

Applicant Xiros Limited

K-Number K242237

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OXH 2025-07-15

Kerecis SurgiBind (50241)

Applicant Kerecis Limited

K-Number K251844

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HGX 2025-07-15

Thrive 2-in-1 Breast Pump (Model P3)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K250350

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LCX 2025-07-15

Shinetell PlusTM Digital Early Pregnancy Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K251053

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JWH 2025-07-14

Materialise TKA Guide System

Applicant Materialise NV

K-Number K251554

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NGX 2025-07-14

CoolTone

Applicant Zimmer Medizinsysteme GmbH

K-Number K251378

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HRS 2025-07-14

The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws

Applicant Acumed, LLC

K-Number K251132

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OWB 2025-07-14

LUMINOS Q.namix T; LUMINOS Q.namix R

Applicant Siemens Medical Solutions

K-Number K250660

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LLZ 2025-07-14

GECHO

Applicant Narnar, LLC

K-Number K250120

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BZR 2025-07-14

F&P Optiflow Air/Oxygen Flow Source

Applicant Fisher & Paykel Healthcare, Ltd.

K-Number K243917

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HSB 2025-07-14

Phantom® Hindfoot TTC/TC Nail System

Applicant Paragon 28, Inc.

K-Number K251850

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