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

PBF 2025-10-21

Fine TTO™

Applicant Bodycad Laboratories, Inc.

K-Number K250394

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MBI 2025-10-21

Aevumed FASE Suture Anchor

Applicant Aevumed, Inc.

K-Number K253040

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DYB 2025-10-21

Introducer Sheath Set

Applicant Cardiocycle Medical(Suzhou) Co., Ltd.

K-Number K251838

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HAW 2025-10-21

NeuroAlign software

Applicant Medivis, Inc.

K-Number K231897

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FGE 2025-10-21

Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)

Applicant Olympus Medical Systems Corporation

K-Number K250409

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DQK 2025-10-21

HemoSphere Stream Module

Applicant Edwards Lifesciences

K-Number K253034

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ONB 2025-10-21

Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

Applicant Simplivia Healthcare , Ltd.

K-Number K253033

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NKB 2025-10-21

TriALTIS™ Spine System

Applicant Medos International SARL

K-Number K253249

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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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