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

GEI 2025-10-21

ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)

Applicant Livsmed, Inc.

K-Number K250126

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KOI 2025-10-21

Neuromuscular Transmission Monitor TOF3D (2510091)

Applicant MIPM Mammendorfer Institut für Physik und Medizin GmbH

K-Number K250887

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ONG 2025-10-20

AVAVA Skin Treatment System

Applicant AVAVA, Inc.

K-Number K252155

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GCJ 2025-10-20

VereSee Optical Veres Needle and Endoscopic Camera

Applicant Freyja Healthcare, LLC

K-Number K252640

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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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SFW 2025-10-17

Modius Lean

Applicant Neurovalens Limited

K-Number DEN240076

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HSB 2025-10-17

Estremo Fibular Nail

Applicant Citieffe S.R.L.

K-Number K250197

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