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

DXN 2026-04-01

Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)

Applicant Shenzhen HanHan Technology Co., Ltd.

K-Number K254225

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OAS 2026-03-31

Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)

Applicant VATECH Co., Ltd.

K-Number K260093

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LLZ 2026-03-31

RW-1

Applicant Mediott, Inc.

K-Number K253029

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FBK 2026-03-31

InjecSURE Injection System

Applicant Carbon Medical Technologies, Inc.

K-Number K253598

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IOR 2026-03-31

K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated foot rest(ELR) 18” with elevated foot rest(ELR) 20” with elevated foot rest(ELR))

Applicant Zhenjiang Assure Medical Equipment Co., Ltd.

K-Number K260319

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GEX 2026-03-31

Nd: YAG Laser Therapy Systems

Applicant Sanhe Meditech Co., Ltd.

K-Number K260375

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FMK 2026-03-31

Safety lancet (XXXVII)

Applicant Tianjin Huahong Technology Co., Ltd.

K-Number K260191

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QOF 2026-03-30

FINDER Flu A&B/SARS-CoV-2 Test

Applicant Baebies, Inc.

K-Number K252269

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GEI 2026-03-30

FLOW FLEXTEND Wand (72290039)

Applicant ArthroCare Corporation

K-Number K254122

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SGA 2026-03-30

Francisella tularensis Real-time PCR Assay

Applicant Centers for Disease Control and Prevention

K-Number K260812

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LLZ 2026-03-30

Avatar Medical Vision

Applicant Avatar Medical

K-Number K253950

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MSX 2026-03-30

IntelliVue Measurement Rack 6000 (867317)

Applicant Philips Medizin Systeme Böblingen GmbH

K-Number K253654

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