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

DZE 2016-03-16

NobelZygoma 45°

Applicant Nobel Biocare AB

K-Number K152093

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HRX 2016-03-16

SPINAUT-V, SPINAUT-S, SPINAUT-I

Applicant Imedicom Co., Ltd.

K-Number K151268

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HBE 2016-03-16

DReal

Applicant Carevature Medical, Ltd.

K-Number K153519

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PEN 2016-03-15

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

Applicant Biofire Diagnostics, LLC

K-Number K160457

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LJT 2016-03-15

Dignity Dual Port

Applicant Medcomp ( Medical Components)

K-Number K153238

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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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