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 2026-08-26

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)

Applicant JOYTECH Healthcare Co., Ltd.

K-Number K261394

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HRX 2026-08-26

HOPKINS Telescopes for Arthroscopy

Applicant Karl Storz SE & CO. KG

K-Number K254103

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FGB 2026-08-26

LithoVue Elite Digital Flexible Ureteroscope System

Applicant Boston Scientific Corporation

K-Number K261153

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GCJ 2026-08-26

OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor

Applicant Sony Corporation

K-Number K260972

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QIH 2026-08-26

Heartvue.Proton

Applicant Heartvue.ai, Inc.

K-Number K260811

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KIF 2026-08-25

Calcium Hydroxide Temporary Filling Material (KP-Cal)

Applicant Guilin Kevin Peter Technology Co., Ltd.

K-Number K261514

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QIH 2026-08-25

Ceevra Reveal 4

Applicant Ceevra, Inc.

K-Number K261595

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FMF 2026-08-25

SOL-M Luer Lock Syringe with Exchangeable Needle Tray

Applicant Sol-Millennium Medical, Inc.

K-Number K252184

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GEI 2026-08-25

Inno-Switch™ Laparoscopic Instruments

Applicant Taiwan Surgical Corporation

K-Number K252535

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OLV 2026-08-25

Report Studio

Applicant Beacon Biosignals, Inc.

K-Number K261747

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FMI 2026-08-25

Promisemed X-Safety Pen Needle

Applicant Promisemed Hangzhou Meditech Co., Ltd.

K-Number K261719

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QRK 2026-08-25

Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K262631

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