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

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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HRS 2026-08-13

MIKRON TRAUMA BONE PLATE& SCREW SYSTEM

Applicant Mikron Makina San. ve Tic. Ltd. Sti.

K-Number K260277

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KNW 2026-08-12

Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)

Applicant Hologic, Inc.

K-Number K262792

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QDQ 2026-08-12

CadAI-B Dx

Applicant BeamWorks, Inc.

K-Number K260086

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HWC 2026-08-12

Large Compression Screws

Applicant TriMed, Inc.

K-Number K262344

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