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

PGN 2020-07-30

MAGEC® System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K201543

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JWH 2020-07-30

EXULT Femoral component trial - Left, EXULT Femoral component trial - Right

Applicant Corentec Co., Ltd.

K-Number K201851

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PIF 2020-07-30

BD Univia RightFit Enteral Extension Sets and Transitional Adapters

Applicant Mps Medical, Inc.

K-Number K200082

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IYN 2020-07-30

S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System

Applicant Sonoscape Medical Corp.

K-Number K201059

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DQX 2020-07-29

Zoom 14 Guidewire

Applicant Scientia Vascular, LLC

K-Number K201760

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KTT 2020-07-29

Pitkar External Fixation System - Rail Mechanism

Applicant S.H.Pitkar Orthotools Pvt. , Ltd.

K-Number K200518

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LZO 2020-07-29

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling

Applicant Biomet UK, Ltd.

K-Number K200959

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FYA 2020-07-29

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

Applicant Cardinal Health200, LLC

K-Number K200824

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KGN 2020-07-29

Symphony

Applicant Aroa Biosurgery , Ltd.

K-Number K200413

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DQO 2020-07-29

Superpipe Angiographic Catheter

Applicant Suzhou Hengrui Disheng Medical Co., Ltd.

K-Number K193647

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HIF 2020-07-29

PNEUMOCLEAR

Applicant W.O.M. World of Medicine GmbH

K-Number K201361

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JEY 2020-07-29

BoniPlus Dental G-Mesh System

Applicant Montjade Engineering Co., Ltd.

K-Number K182759

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