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

KPE 2025-04-18

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution

Applicant Technoflex Sas.

K-Number K250459

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NGX 2025-04-18

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K250146

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FMI 2025-04-18

FROG (Filter Removal of Glass)

Applicant Carrtech Corp

K-Number K240355

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PSZ 2025-04-18

Acucy® Influenza A&B Test with the Acucy® 2 System

Applicant SEKISUI Diagnostics, LLC

K-Number K241188

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PKL 2025-04-18

PADLOCK CLIP EFTR Kit (00713229)

Applicant STERIS Corporation

K-Number K250842

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MQB 2025-04-18

Wireless/ Wired X-Ray Flat Panel Detectors

Applicant Allengers Medical Systems Limited

K-Number K243734

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DXZ 2025-04-18

PeriBeam® Pericardial Membrane

Applicant Tamabio

K-Number K240775

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PEN 2025-04-18

LIAISON PLEX Gram-Negative Blood Culture Assay

Applicant Luminex Corporation

K-Number K243013

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OBP 2025-04-17

Ultimate rTMS

Applicant Brain Ultimate, Inc.

K-Number K243460

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HGX 2025-04-17

Lacevo Wearable Breast Pump (Model S70)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K250829

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DQY 2025-04-17

FlowGuide (FG60F); GuidionShort (GS60F)

Applicant Imds Operations B.V.

K-Number K242337

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SEM 2025-04-17

Minder System

Applicant Epi-Minder Pty, Ltd.

K-Number DEN240062

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