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

MSD 2025-05-16

Hemodialysis Catheter

Applicant Haolang Medical USA Corporation

K-Number K241581

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SET 2025-05-16

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio

Applicant Fujirebio Diagnostics,Inc.

K-Number K242706

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HRX 2025-05-16

Arthrex Spine Endoscope

Applicant Arthrex, Inc.

K-Number K243602

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JAK 2025-05-16

Spectral CT

Applicant Philips Medical Systems Technologies , Ltd.

K-Number K244008

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FKX 2025-05-16

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1

Applicant Byonyks Pvt, Ltd.

K-Number K243371

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NDY 2025-05-16

Cystatin C

Applicant SENTINEL CH. SpA

K-Number K242585

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OWB 2025-05-16

MasteRad MiniX Mobile Digital Imaging System (Mini-X)

Applicant Medicatech USA, Inc.

K-Number K242731

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LZO 2025-05-15

NEXUS® Hip Stem

Applicant Microport Orthopedics, Inc.

K-Number K250444

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IYN 2025-05-15

Lumify Diagnostic Ultrasound System

Applicant Philips Ultrasound

K-Number K242519

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LDF 2025-05-15

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)

Applicant C.R. Bard, Inc.

K-Number K251186

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NGX 2025-05-15

Limfa Therapy System (Limfa Therapy)

Applicant Eywa Srl

K-Number K243165

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QHH 2025-05-15

NeurAxis IB-Stim (01-1020)

Applicant Neuraxis

K-Number K250451

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