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

NGX 2026-08-13

High Intensity Focused Electromagnetic Stimulation Device (FE60)

Applicant Beijing Winkonlaser Technology Limited

K-Number K253790

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LNH 2026-08-13

AIR Recon DL

Applicant GE Medical Systems

K-Number K253808

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EBI 2026-08-13

UltraPrint Flexible Denture UV

Applicant Guangzhou Heygears IMC., Inc.

K-Number K261626

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MSX 2026-08-13

Dashboard (P007000)

Applicant Hill-Rom, Inc.

K-Number K260211

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KLW 2026-08-13

Levo Gen 2 Tinnitus Therapy System

Applicant Levo Medical Corporation

K-Number K260413

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DXN 2026-08-13

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)

Applicant Joytech Healthcare Co. , Ltd.

K-Number K253425

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OLW 2026-08-13

BIS™ Advance pEEG Module

Applicant Covidien LP

K-Number K260907

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GCJ 2026-08-13

VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)

Applicant Freyja Healthcare, LLC

K-Number K261139

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EMA 2026-08-13

Any-Cem

Applicant Mediclus Co., Ltd.

K-Number K254201

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DXN 2026-08-13

BP Go (BPP-855)

Applicant Wellvii, Inc.

K-Number K261061

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NRY 2026-08-13

CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set

Applicant CERENOVUS, Inc.

K-Number K262398

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BSK 2026-08-13

TrachFlush

Applicant Aw Technologies Aps

K-Number K261499

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