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

NEW 2025-10-20

Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)

Applicant Feeltech Co., Ltd.

K-Number K251414

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DSY 2025-10-20

Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)

Applicant Vascular Flow Technologies Limited

K-Number K252277

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MOS 2025-10-20

InkSpace Imaging Small Body Array (SBA12PH30x)

Applicant Inkspace Imaging, Inc.

K-Number K253182

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NKB 2025-10-20

A8 INTEGR8™ Porous Pedicle Screws

Applicant Allumin8, Inc.

K-Number K242827

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QIH 2025-10-20

brAIn™ Shoulder Positioning

Applicant Avatar Medical

K-Number K252665

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GEX 2025-10-20

Q-Switched Nd: YAG Laser machine (LFS-C13U)

Applicant Sanhe Lefis Electronics Co., Ltd.

K-Number K252319

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HSB 2025-10-17

Estremo Fibular Nail

Applicant Citieffe S.R.L.

K-Number K250197

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MHX 2025-10-17

IntelliVue Patient monitors MX400, MX450, MX500, MX550

Applicant Philips Medizin Systeme Boeblingen GmbH

K-Number K251146

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HCG 2025-10-17

InZone IST Detachment System; IZDS Connecting Cable

Applicant Stryker Neurovascular

K-Number K251832

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IYE 2025-10-17

MOSkin Radiation Measurement System

Applicant Electrogenics Labs, Ltd.

K-Number K250911

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JZO 2025-10-17

ADVIA Centaur Anti-Thyroid Peroxidase II

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K250250

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OBR 2025-10-17

Remi Custom Night Guard

Applicant Remi

K-Number K251778

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