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

OWB 2026-03-10

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

Applicant Canon Medical Systems Corporation

K-Number K253584

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NVK 2026-03-10

Gemini NOVA 810+980 Soft Tissue Laser

Applicant Azena Medical, LLC

K-Number K260765

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HSB 2026-03-10

Reselute Tibial Nail

Applicant Reselute, Inc.

K-Number K253517

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N/A 2026-03-10

DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System

Applicant Synthes GmbH

K-Number K254093

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DZE 2026-03-10

Straumann® BLC Implants - Indication Widening

Applicant Institut Straumann AG

K-Number K252168

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EIH 2026-03-10

IPS e.max Zirconia

Applicant Ivoclar Vivadent, Inc.

K-Number K253953

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OAS 2026-03-10

myray ProXIma X6

Applicant Cefla S.C.

K-Number K252353

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ELC 2026-03-10

Varios Combi Pro2

Applicant Nakanishi, Inc.

K-Number K260773

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PCH 2026-03-09

QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

Applicant QIAGEN GmbH

K-Number K254032

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HRS 2026-03-09

DePuy Synthes VOLT Proximal Tibia 3.5 Plating System

Applicant Synthes GmbH

K-Number K260069

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MBI 2026-03-09

FiberTape Button

Applicant Arthrex, Inc.

K-Number K260405

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NFT 2026-03-09

Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup

Applicant WEBEST Biotech,, LLC

K-Number K260355

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