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

JWH 2019-06-04

Vanguard XP Knee System

Applicant Zimmer, Inc.

K-Number K190068

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NEW 2019-06-04

PDS Barbed Suture, PDO MAXX Threads

Applicant Pdo Max, Inc.

K-Number K190245

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KNT 2019-06-04

CORTRAK* 2 Equilateral Enteral Access System

Applicant Avanos Medical, Inc.

K-Number K191340

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LNH 2019-06-04

Achieva 1.5T, 3.0T and Intera 1.5T MR Systems

Applicant Philips Medical Systems Nederland B.V.

K-Number K190461

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NBW 2019-06-04

TD-4183 Blood Glucose Monitoring System

Applicant Taidoc Technology Corporation

K-Number K190579

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PHL 2019-06-03

ReWalk Restore

Applicant Re Walk Robotics , Ltd.

K-Number K190337

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NKG 2019-06-03

Solanas® Posterior OCT Fixation System

Applicant Alphatec Spine

K-Number K191185

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LDD 2019-06-03

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors

Applicant Physio-Control, Inc.

K-Number K182503

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KIF 2019-06-03

Diapex Plus

Applicant DiaDent Group International

K-Number K182625

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NBW 2019-06-02

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB

Applicant Bionime Corporation

K-Number K190564

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NHN 2019-06-01

Erchonia FX-635

Applicant Erchonia Corporation

K-Number K190572

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KWQ 2019-05-31

Cervical Plate

Applicant Eisertech, LLC

K-Number K190565

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