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

BTY 2026-08-20

CPETWise Platform

Applicant Medibyt , Ltd.

K-Number K260242

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SET 2026-08-19

Elecsys Phospho-Tau (217P) Plasma

Applicant Roche Diagnostics

K-Number K261686

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LNH 2026-08-19

Swoop® Portable MR Imaging® System

Applicant Hyperfine, Inc.

K-Number K262622

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SET 2026-08-19

PrecivityAD2 Test

Applicant C2N Diagnostics, LLC

K-Number K253240

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OWB 2026-08-19

EXTRON 3;EXTRON 6

Applicant DRTECH Corporation

K-Number K261413

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HRS 2026-08-19

Versalock Sterile Plating System

Applicant GM Dos Reis Industria e Comercio Ltda.

K-Number K262537

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DZE 2026-08-19

ZEROS Dental Implant System

Applicant Zeros Co., Ltd.

K-Number K260463

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GEX 2026-08-19

ECHOLASER X4

Applicant Elesta S.P.A

K-Number K261964

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LXB 2026-08-19

Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)

Applicant Shokz Health Global Limited

K-Number K253431

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GEX 2026-08-19

Diode Laser Therapy Systems (DL612A)

Applicant Hebei Zollvan Medical Technology Co., Ltd.

K-Number K262070

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OLT 2026-08-19

Pascall Sensor Unit (PSU1)

Applicant Pascall Systems, Inc.

K-Number K254213

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MQG 2026-08-19

Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)

Applicant CooperSurgical, Inc.

K-Number K261083

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