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

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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PDZ 2026-03-09

Medicell Mycosis Laser (MCML24004)

Applicant Medicell Healthcare Co.,LTD

K-Number K253960

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HGX 2026-03-09

Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K253934

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PBX 2026-03-09

NeoSculpt Plus

Applicant S&M Medical Co., Ltd.

K-Number K252888

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LNH 2026-03-09

LiverMultiScan (v6.0)

Applicant Perspectum, Ltd.

K-Number K253413

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FDT 2026-03-09

FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000

Applicant Fujifilm Corporation

K-Number K251861

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MBH 2026-03-09

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)

Applicant Zimmer, Inc.

K-Number K253189

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