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

LLZ 2016-08-10

5D Viewer

Applicant Samsung Medison Co., Ltd.

K-Number K161955

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JAK 2016-08-10

SpotLight CT

Applicant Arineta , Ltd.

K-Number K161066

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DPS 2016-08-09

Quantitative Electrocardiographic Detector (QED 2000)

Applicant Acme Portable Machines, Inc.

K-Number K152135

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LHN 2016-08-09

Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)

Applicant Ion Beam Application S.A.

K-Number K152224

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KNT 2016-08-09

Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet

Applicant Syncro Medical Innovations, Inc.

K-Number K160787

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NKB 2016-08-09

Genesys Spine TiLock Cortical Spinal System

Applicant Genesys Spine

K-Number K161914

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LLZ 2016-08-09

icobrain

Applicant Icometrix

K-Number K161148

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POX 2016-08-09

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

Applicant Ark Diagnostics, Inc.

K-Number K153596

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LRK 2016-08-09

SnoreRx

Applicant Apnea Sciences Corporation

K-Number K153200

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MSD 2016-08-09

NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)

Applicant Marvao Medical Devices, Ltd.

K-Number K161026

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JAK 2016-08-08

P-ARTIS

Applicant P-Cure, Ltd.

K-Number K160611

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FRO 2016-08-08

PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove

Applicant Permeaderm, Inc.

K-Number K153678

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