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

DYB 2019-07-25

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

Applicant Access Scientific, LLC

K-Number K183066

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OCC 2019-07-24

Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

Applicant Roche Molecular Systems, Inc.

K-Number K191729

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OBO 2019-07-24

Canon OCT-A1

Applicant Canon, Inc.

K-Number K182942

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MRC 2019-07-24

MaxiTears Contacts PF

Applicant Omnivision AG

K-Number K182984

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NKB 2019-07-24

4CIS® Chiron Spinal Fixation System

Applicant Solco Biomedical Co., Ltd.

K-Number K190471

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GEI 2019-07-24

TempSure

Applicant Cynosure, Inc.

K-Number K190678

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OLO 2019-07-24

ExcelsiusGPS Spine 1.1 Interbody Module

Applicant Globus Medical, Inc.

K-Number K191100

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OCL 2019-07-24

Coolrail Linear Pen

Applicant AtriCure, Inc.

K-Number K190587

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KPR 2019-07-24

Discovery XR656 HD with VolumeRad

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K191699

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HRS 2019-07-23

DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional

Applicant Synthes (USA) Products, LLC

K-Number K190963

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LNH 2019-07-23

Vantage Orian 1.5T, MRT-1550, V4.5

Applicant Canon Medical Systems Corporation

K-Number K191662

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MAX 2019-07-23

ProLift Expandable System

Applicant Life Spine, Inc.

K-Number K190488

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