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

OVE 2016-08-01

Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System

Applicant Spinal Elements, Inc.

K-Number K153352

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HQD 2016-08-01

SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens

Applicant Synergeyes, Inc.

K-Number K160938

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PBX 2016-08-01

EndyMed Contour Handpiece

Applicant Endymed Medical, Ltd.

K-Number K161199

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FLL 2016-08-01

Infra-red forehead thermometer

Applicant Hangzhou Hua'An Medical&Health Instruments Co.,Ltd

K-Number K160999

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HWC 2016-08-01

The Hammertoe Correction System

Applicant Life Spine, Inc.

K-Number K153065

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LIT 2016-07-30

Pirouette 035

Applicant Arravasc Limited

K-Number K161427

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LOX 2016-07-30

Mozec NC-Rx PTCA Baloon Dilatation Catheter

Applicant Meril Life Sciences Private Limited

K-Number K160961

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OCO 2016-07-29

The Luco Hybrid OSA Appliance

Applicant Luco Hybrid Osa Appliance, Inc.

K-Number K160477

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OWB 2016-07-29

2D Quantitative Analysis

Applicant Philips Medical Systems Nederland B.V.

K-Number K161839

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EBF 2016-07-29

Clip Flow

Applicant Voco GmbH

K-Number K153493

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OWB 2016-07-29

Allura Xper FD series and Allura Xper OR Table series

Applicant Philips Medical Systems Nederland B.V.

K-Number K161563

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ILY 2016-07-29

HeatLux Pro II

Applicant Home Skinovations , Ltd.

K-Number K152087

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