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

KPS 2025-07-31

Biograph Trinion

Applicant Siemens Medical Solutions USA, Inc.

K-Number K251561

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LEL 2025-07-31

Sleep Watch

Applicant Ambulatory Monitoring, Inc.

K-Number K251574

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QDQ 2025-07-31

Genius AI Detection 2.0

Applicant Hologic, Inc.

K-Number K243341

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MBH 2025-07-31

U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella

Applicant United Orthopedic Corporation

K-Number K243656

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KPR 2025-07-31

YSIO X.pree

Applicant Siemens Medical Solutions

K-Number K250738

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SBF 2025-07-31

NextAR(TM) Spine

Applicant Medacta International S.A.

K-Number K250477

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JDI 2025-07-31

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

Applicant Zimmer Biomet

K-Number K243571

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HGX 2025-07-31

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K250843

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MSX 2025-07-31

BeneVision Central Monitoring System

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K242728

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KWZ 2025-07-31

Mpact Constrained Liner

Applicant Medacta International S.A.

K-Number K241461

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ONG 2025-07-31

eCO2 3D

Applicant Lutronic Corporation

K-Number K244060

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QOF 2025-07-31

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems

Applicant Roche Molecular Systems, Inc.

K-Number K243455

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