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

QEW 2025-06-13

Excipio LV Prime Thrombectomy Device

Applicant Contego Medical, Inc.

K-Number K251485

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DQX 2025-06-13

Medtronic Stedi Extra Support Guidewire

Applicant Medtronic, Inc.

K-Number K250075

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ITX 2025-06-13

Accuro® 3S Needle Guide Kit

Applicant Rivanna Medical, Inc.

K-Number K250469

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QVF 2025-06-13

BinaxNOW COVID-19 Ag Card

Applicant Abbott Diagnostics Scarborough, Inc.

K-Number K250273

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ETN 2025-06-13

ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

Applicant Inomed Medizintechnik GmbH

K-Number K242852

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HWC 2025-06-13

Eleganz Fusion Screw System (Fusion Screw System)

Applicant Dev4

K-Number K250251

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EOQ 2025-06-13

FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000

Applicant Fujifilm Corporation

K-Number K244017

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JCX 2025-06-13

MV Flow Aspiration Pump (MVFLOWPMP01)

Applicant Microvention

K-Number K243638

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MEH 2025-06-13

Mfinity Femoral System

Applicant Medacta International S.A.

K-Number K251166

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QIH 2025-06-13

Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

Applicant Brainlab AG

K-Number K243633

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QEW 2025-06-13

Aventus Thrombectomy System

Applicant Inquis Medical

K-Number K251189

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KDI 2025-06-13

2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)

Applicant Fresenius Medical Care Renal Therapies Group, LLC

K-Number K243237

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