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

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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QAS 2019-05-31

BriefCase

Applicant Aidoc Medical , Ltd.

K-Number K190896

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GEH 2019-05-31

C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

Applicant Pentax Medical, A Division of Pentax of America, Inc.

K-Number K190194

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OVE 2019-05-31

NEXXT MATRIXX Stand Alone Cervical System

Applicant Nexxt Spine, LLC

K-Number K190546

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FRO 2019-05-31

Apis

Applicant Sweetbio, Inc.

K-Number K182725

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LNH 2019-05-31

MAGNETOM Avanto Fit

Applicant Siemens Medical Solution USA, Inc.

K-Number K190757

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LOD 2019-05-31

PALACOS fast R+G

Applicant Heraeus Medical GmbH

K-Number K190766

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MMK 2019-05-31

Tiger Sharps Containers

Applicant International Marketing Specialists, Inc.

K-Number K190240

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