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

NQE 2018-01-19

EM-4000 Specular Microscope

Applicant Tomey Corporation

K-Number K171313

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OBO 2018-01-19

DRI OCT Triton

Applicant Topcon Corporation

K-Number K173119

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OAS 2018-01-19

PreXion3D Excelsior

Applicant Prexion Corporation

K-Number K173878

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DXG 2018-01-18

PulsioFlex Monitoring System

Applicant Pulsion Medical Systems SE

K-Number K172259

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OLO 2018-01-18

Navigated INFINITY Instruments

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K173338

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OWN 2018-01-18

Stryker AIM Light Source and SafeLight cable

Applicant Stryker

K-Number K173866

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HET 2018-01-18

Flex Robotic System and Flex Transabdominal Drive

Applicant Medrobotics Corporation

K-Number K172796

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HRX 2018-01-18

FMS VUE II Fluid Management and Tissue Debridement System

Applicant Medos International SARL

K-Number K171237

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MAX 2018-01-18

Tritanium® TL Curved Posterior Lumbar Cage

Applicant Stryker

K-Number K173476

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OHT 2018-01-18

Lumilisse IPL Hair Remover

Applicant Conair Corporation

K-Number K172791

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FED 2018-01-18

BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap

Applicant Baronova, Inc.

K-Number K172575

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KNS 2018-01-18

Barrx SB RFA Endoscopic Catheter

Applicant Covidien, LLC

K-Number K173559

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