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

QIH 2025-08-15

VEA Align; spineEOS

Applicant Eos Imaging

K-Number K251747

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HWC 2025-08-15

Dunamis Screw and Suture Locking System

Applicant Dunamis Medical, LLC

K-Number K250867

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DSH 2025-08-15

Zio® monitor (DFG0001)

Applicant iRhythm Technologies, Inc.

K-Number K243650

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DJG 2025-08-15

Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)

Applicant Healgen Scientific,, LLC

K-Number K251972

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HSX 2025-08-15

Persona Partial Knee

Applicant Zimmer Biomet

K-Number K251834

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MAX 2025-08-15

Atlas Spine Project X Expandable Posterior Lumbar Interbody System

Applicant Atlas Spine, Inc.

K-Number K251969

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PBH 2025-08-15

CHLOE BLAST

Applicant Fairtility , Ltd.

K-Number K243851

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GXI 2025-08-15

OneRF Trigeminal Nerve Radiofrequency Probes

Applicant Neuroone Medical Technologies Corp.

K-Number K251243

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KGN 2025-08-15

Helios Dermal Scaffold

Applicant Helios Biomedical, Inc.

K-Number K250397

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LTT 2025-08-15

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)

Applicant Beckman Coulter, Inc.

K-Number K250036

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QRG 2025-08-15

Nerveblox

Applicant Smart Alfa Teknoloji San. Ve Tic. A.S.

K-Number K250818

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OHT 2025-08-14

IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)

Applicant Shenzhen Mlay Intelligent Technology Co., , Ltd.

K-Number K251176

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