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

SEI 2026-04-07

Elecsys Anti-HBc II

Applicant Roche Diagnostics

K-Number K260046

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ITI 2026-04-07

Power Wheelchair (OS-R-M01S)

Applicant Beijing OrionStar Technology Co., Ltd.

K-Number K253952

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HGX 2026-04-07

Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K253946

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LOL 2026-04-07

Elecsys Anti-HAV IgM

Applicant Roche Diagnostics

K-Number K260048

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HQF 2026-04-07

Voyager DSLT (430840610)

Applicant Belkin Vision, Ltd.

K-Number K252979

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DYB 2026-04-06

VANES Delivery System (VDS)

Applicant Zoll Respicardia, Inc.

K-Number K260459

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KWS 2026-04-06

AETOS Shoulder System - CONCELOC Glenoids

Applicant Smith & Nephew, Inc.

K-Number K254084

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EBD 2026-04-06

GLOSSY COAT (15ML)

Applicant YAMAHACHI DENTAL MFG., Co.

K-Number K254091

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PLC 2026-04-06

ProSomnus RPMO2 OSA Device (RPMO2 OSA)

Applicant Prosomnus Sleep Technologies

K-Number K252765

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QRC 2026-04-06

in2 Smart (in2S)

Applicant Virility Medical , Ltd.

K-Number K252809

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IXI 2026-04-06

Ricoh 3D for Healthcare Bolus

Applicant Ricoh 3D For Healthcare, LLC

K-Number K253025

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FED 2026-04-06

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

Applicant Zhuhai Pusen Medical Technology Co., Ltd.

K-Number K260521

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