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

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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NFJ 2023-08-28

CALLISTO eye

Applicant Carl Zeiss Meditec, AG

K-Number K231676

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LZA 2023-08-28

KIMTECH Polaris Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid

Applicant Kimberly-Clark Corporation

K-Number K231435

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JDR 2023-08-28

Treace Medical Concepts (TMC) Compression Implant System

Applicant Treace Medical Concepts

K-Number K232387

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HRS 2023-08-28

Distal Elbow Plating System

Applicant Skeletal Dynamics, Inc.

K-Number K231623

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QTZ 2023-08-28

VisAble.IO

Applicant Techsomed

K-Number K223639

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GEX 2023-08-25

Lavieen

Applicant Wontech Co., Ltd.

K-Number K223727

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