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

DPS 2016-03-15

MODEL 621/624 BIOMAGNETOMETER

Applicant Tristan Technologies, Inc.

K-Number K151135

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NQW 2016-03-15

Xspan Laminoplasty Fixation System

Applicant X-Spine Systems, Inc.

K-Number K160114

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LLZ 2016-03-15

ArthrexVIP Web Portal

Applicant Custom Orthopaedic Solutions, Inc.

K-Number K153612

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KTW 2016-03-15

AOS Anterolateral Proximal Humeral Plate

Applicant Advanced Orthopaedic Solutions, Inc.

K-Number K160409

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GEX 2016-03-15

PerioLase Nd:YAG Pulsed Dental Laser System

Applicant Millennium Dental Technologies, Inc.

K-Number K151763

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PEW 2016-03-15

NeoTract UroLift System UL500

Applicant Neotract, Inc.

K-Number K153584

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FTM 2016-03-15

Endoform Reconstructive Template

Applicant Aroa Biosurgery Limited (Formerly Mesynthes Limited)

K-Number K153633

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MWI 2016-03-15

AlertWatch: OR

Applicant Alertwatch, LLC

K-Number K153335

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OLZ 2016-03-14

Sleep Profiler

Applicant Advanced Brain Monitoring, Inc.

K-Number K153412

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KPR 2016-03-14

Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,

Applicant Summit Industries, LLC

K-Number K153119

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LYR 2016-03-14

ImmunoCard STAT! HpSA

Applicant Meridian Bioscience, Inc.

K-Number K153661

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NHA 2016-03-14

Allied Biocompat Abutment for Nobel Replace Interface

Applicant Allied Dental Solutions

K-Number K152845

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