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

PIF 2025-04-18

Extension Feeding Set with ENFit™ Connectors

Applicant SKY Medical, a.s.

K-Number K250481

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LZO 2025-04-18

Zimmer Biomet Ceramic Heads (22.2mm diameter)

Applicant Zimmer Biomet

K-Number K250834

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ONE 2025-04-18

handLITE (TN19S)

Applicant iSMART Developments, Ltd.

K-Number K250224

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DCK 2025-04-18

K-ASSAY CRP (Ver.2)

Applicant Kamiya Biomedical Company, LLC

K-Number K242170

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IZL 2025-04-18

ULTRA 1040

Applicant Ecoray Co., Ltd.

K-Number K241996

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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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