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

PZX 2023-08-30

LAA Exclusion System

Applicant Syntheon, LLC

K-Number K232295

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DQY 2023-08-30

Ventrax™ Delivery System (VTR851)

Applicant Merit Medical Systems, Inc.

K-Number K231246

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DQA 2023-08-29

circul™ pro Ring

Applicant Bodimetrics, LLC

K-Number K221361

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PHX 2023-08-29

ARROW Off-Centred Humeral Insert

Applicant FH Industrie

K-Number K232226

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FZP 2023-08-29

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

Applicant Ethicon Endo Surgery, LLC

K-Number K232313

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HIF 2023-08-29

StarFin

Applicant Premium Medical Technology, LLC

K-Number K231407

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HSB 2023-08-29

Precice Ankle Salvage System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K230765

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PDU 2023-08-28

SoundBite® Crossing System XS Peripheral

Applicant Soundbite Medical Solutions, Inc.

K-Number K230159

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FCG 2023-08-28

Precision GI

Applicant Limaca Medical, Ltd.

K-Number K231422

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OHV 2023-08-28

SofWave System

Applicant Sofwave Medical, Ltd.

K-Number K231537

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IYX 2023-08-28

QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)

Applicant Versant Medical Physics and Radiation Safety

K-Number K230221

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BZG 2023-08-28

Alveoair Digital Spirometer

Applicant Roundworks Technologies Private Limited

K-Number K222525

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