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

EBW 2026-01-30

Motor Handpiece and Control Unit (SDI10)

Applicant Saeshin Precision Co., Ltd.

K-Number K251407

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POK 2026-01-30

RevealAI-Lung

Applicant Precision Medical Ventures, Inc. Dba Revealdx

K-Number K251769

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KDN 2026-01-30

BAROguard Donor Lung Preservation System

Applicant Paragonix Technologies, Inc.

K-Number K254305

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EIH 2026-01-30

BruxZir® Shaded 16 PLUS

Applicant Prismatik Dentalcraft, Inc.

K-Number K254283

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FDF 2026-01-30

Disposable Distal End Tape Hood

Applicant Shanghai SeeGen Photoelectric Technology Co., Ltd.

K-Number K252457

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GEI 2026-01-30

ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)

Applicant Shenzhen Peninsula Medical Group

K-Number K254290

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DWF 2026-01-30

Dual Stage Venous Cannulae

Applicant Sorin Group Italia S.R.L.

K-Number K253671

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OHS 2026-01-30

Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

Applicant Shenzhen Jianchao Intelligent Technology Co., Ltd.

K-Number K253833

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GEX 2026-01-30

Boston PICO (Boston PICO)

Applicant Boston Aesthetics, Inc.

K-Number K251981

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GQG 2026-01-30

Clungene RSV Antigen Rapid Test

Applicant Hangzhou Clongene Biotech Co., Ltd.

K-Number K253318

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SCL 2026-01-30

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)

Applicant Asistan Medikal

K-Number K250983

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NHA 2026-01-29

EK MULTI ANGLED 30 ABUTMENT

Applicant Hiossen, Inc.

K-Number K251427

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