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

OTD 2018-11-21

Heli-FX EndoAnchor System

Applicant Medtronic Vascular, Inc.

K-Number K182957

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QDQ 2018-11-21

Transpara

Applicant Screenpoint Medical B.V.

K-Number K181704

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HWC 2018-11-21

DePuy Synthes 2.0 mm Quick Insertion Screws

Applicant Synthes USA Products, LLC

K-Number K180541

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LRK 2018-11-21

ApnoDent Appliance

Applicant Apnomed, Inc.

K-Number K181123

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EBF 2018-11-20

TPH Spectra ST Flowable Composite Restorative

Applicant Dentsply Sirona

K-Number K182288

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GWG 2018-11-20

MR Compatible Aspiration Kit

Applicant Mri Interventions, Inc.

K-Number K181731

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FET 2018-11-20

Telepack X LED

Applicant KARL STORZ Endoscopy-America, Inc.

K-Number K182696

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KLE 2018-11-20

GC Acrylic Primer

Applicant GC America, Inc.

K-Number K180917

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PLR 2018-11-20

NuVasive Monolith Cervical Corpectomy System

Applicant Nu Vasive, Incorporated

K-Number K180550

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PGY 2018-11-20

6MP Color LCD Monitor (C61W+)

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K182291

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LLZ 2018-11-20

Vitrea CT Brain Perfusion

Applicant Vital Images, Inc.

K-Number K181247

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FLL 2018-11-20

COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10

Applicant Kangfu Medical Equipment Factory

K-Number K182652

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