Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

SFD 2025-09-08

Coaptium Connect with Tissium Light

Applicant Tissium SA

K-Number K251957

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HGX 2025-09-08

Momcozy Wearable Breast Pump (BP223)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K251394

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HRS 2025-09-08

MAXXOS P.A.C.E. Foot & Ankle Plating System

Applicant Maxxos Medical GmbH

K-Number K251892

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JAK 2025-09-08

OmniTom Elite with PCD

Applicant Neurologica Corporation

K-Number K250928

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JWY 2025-09-05

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL

Applicant Thermo Fisher Scientific

K-Number K250575

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FED 2025-09-05

Ureteral Access Sheath

Applicant Zhejiang YiGao Medical Technology Co., Ltd.

K-Number K250132

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MNR 2025-09-05

WatchPAT400 (WP400)

Applicant Itamar Medical , Ltd.

K-Number K250460

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KGI 2025-09-05

3D-SHAPER

Applicant 3D-Shaper Medical S.L

K-Number K251022

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QYT 2025-09-05

GenaCheck COVID-19 Rapid Self-Test

Applicant Genabio Diagnostics, Inc.

K-Number K251753

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LJT 2025-09-05

Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port

Applicant Bard Access Systems, Inc.

K-Number K252478

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EOQ 2025-09-05

Ion Endoluminal System (IF1000)

Applicant Intuitive Surgical, Inc.

K-Number K252528

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HAW 2025-09-05

SOLOPASS 2.0 System

Applicant Intravent Medical Partners

K-Number K251317

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