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

IYN 2019-04-02

ARIETTA 50

Applicant Hitachi Healthcare Americas

K-Number K190248

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EBZ 2019-04-01

Le'Pen

Applicant Kmihh, Ltd.

K-Number K181597

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IYN 2019-04-01

7400 Ultrasound Systems

Applicant Navigant Consulting - on Behalf of Esaote S.P.A.

K-Number K190447

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LFL 2019-04-01

CUSA Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K190180

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HSN 2019-04-01

Vantage Total Ankle Flat Cut Talar Components

Applicant Exactech, Inc.

K-Number K183343

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LPH 2019-04-01

Bencox Mirabo Cup Multi Hole

Applicant Corentec Co., Ltd.

K-Number K182221

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HKI 2019-04-01

Microperimeter MP-3, Microperimeter MP-3 Type S

Applicant Nidek Co., Ltd.

K-Number K190198

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LLZ 2019-04-01

DBSWIN and VISTAEASY Imaging Software

Applicant Durr Dental SE

K-Number K190629

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FET 2019-03-29

Pusen Eview Medical Video Endoscope Image Processor

Applicant Zhuhai Pusen Medical Technology Co., Ltd.

K-Number K190648

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JWH 2019-03-29

Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly

Applicant Total Joint Orthopedics, Inc.

K-Number K183596

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JEY 2019-03-29

Delphos Implants Rigid Fixation System

Applicant Delphos Implants - Ind.Com. Importacao E Exportacao DE

K-Number K182609

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KNT 2019-03-29

Micro Transgastric-Jejunal Feeding Device

Applicant Applied Medical Technology, Inc.

K-Number K183508

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