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

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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PMN 2025-08-14

FilmArray GI Control Panel M238

Applicant Maine Molecular Quality Controls, Inc.

K-Number K251526

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NLQ 2025-08-14

Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)

Applicant Stryker Sustainability Solutions

K-Number K250898

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JDQ 2025-08-14

Stitch Cerclage Suture Tapes

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K243905

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NPL 2025-08-14

Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack

Applicant Geistlich Pharma AG

K-Number K251062

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HKI 2025-08-14

3nethra neo HD FA; 3nethra neo HD

Applicant Forus Health Pvt.Ltd

K-Number K243600

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