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

GEX 2025-06-26

Optimas MAX System

Applicant InMode , Ltd.

K-Number K251632

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PDQ 2025-06-26

Neuralytix iD3 System (NTX-9001)

Applicant Neuralytix, LLC

K-Number K243636

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KPI 2025-06-26

NeuroTrac® MyoPlus Pro (MYO120U)

Applicant Verity Medical , Ltd.

K-Number K243079

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FMK 2025-06-26

safety lancet

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K251694

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MUD 2025-06-26

Lap.Ox Laparoscopic Tissue Oximeter

Applicant ViOptix, Inc.

K-Number K250519

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NPM 2025-06-26

SwissGraft X

Applicant Geistlich Pharma AG

K-Number K251613

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OUR 2025-06-26

The Rialto SI Fusion System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K251395

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JWH 2025-06-26

Freedom® Total Knee System Titanium Tibial Base Plate

Applicant Maxx Orthopedics, Inc.

K-Number K251717

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NHA 2025-06-26

Sherlock

Applicant Open Implants, LLC

K-Number K250967

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NYV 2025-06-26

Atmo Gas Capsule System

Applicant Atmo Biosciences, Ltd.

K-Number K250940

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HRS 2025-06-26

TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

Applicant TriMed, Inc.

K-Number K250929

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JTN 2025-06-26

HardyDisk AST Gepotidacin 10µg (GEP10)

Applicant Hardy Diagnostics

K-Number K250956

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