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

FLL 2018-04-19

AViTA Radar Thermo NT16 Series IR Thermometer

Applicant Avita Corporation

K-Number K172427

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NOY 2018-04-19

Embozene Color-Advanced Microspheres

Applicant Boston Scientific

K-Number K180102

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OVD 2018-04-18

ENZA-A Titanium ALIF

Applicant Camber Spine Technologies

K-Number K173432

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MAX 2018-04-18

HALF DOME Posterior Lumbar Interbody System

Applicant Astura Medical

K-Number K172947

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DQY 2018-04-18

Wingman 35 Crossing Catheter

Applicant Reflow Medical, Inc.

K-Number K173661

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GCJ 2018-04-18

Genistrong

Applicant Genicon, Inc.

K-Number K180836

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DYB 2018-04-18

RAILWAY Sheathless Access System

Applicant Cordis Corporation

K-Number K180081

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NKG 2018-04-18

VERTEX Reconstruction System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K180851

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DXN 2018-04-18

Microlife Upper Arm Automatic Digital Blood Pressure Monitor

Applicant Microlife Intellectual Property GmbH

K-Number K172880

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KCT 2018-04-18

Stryker Universal Select Sterilization Tray System

Applicant Paragon Medical

K-Number K173615

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HSD 2018-04-18

OVOMotion Shoulder Arthroplasty System

Applicant Arthrosurface, Inc.

K-Number K173964

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HCG 2018-04-17

Penumbra Coil 400, Ruby Coil System, POD System

Applicant Penumbra, Inc.

K-Number K173614

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