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

PNR 2016-09-22

Enteral Syringe with ENFit Connector (10 ml to 60 ml), Enteral Syringe with ENFit Low Dose Tip (1 ml to 5 ml)

Applicant Vr Medical Technology

K-Number K162188

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NHA 2016-09-21

ATLANTIS ISUS Implant Suprastructures

Applicant Dentsply International, Inc.

K-Number K160207

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DXN 2016-09-21

Full Automatic (NIBP) Blood Pressure Monitor

Applicant Health & Life Co., Ltd.

K-Number K162338

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MNH 2016-09-21

Spinal fixation system

Applicant Canwell Medical Co., Ltd.

K-Number K161151

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MAX 2016-09-21

Cascadia Interbody System

Applicant K2m, Inc.

K-Number K162264

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NAY 2016-09-21

da Vinci Xi 12 – 8 mm Reducer

Applicant Intuitive Surgical, Inc.

K-Number K162411

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IYN 2016-09-21

Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0

Applicant Toshibamedical Systems Corporation

K-Number K161843

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DQY 2016-09-21

Surefire Guiding Catheter

Applicant Surefire Medical, Inc.

K-Number K162359

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LLZ 2016-09-21

Scenium

Applicant Siemens Medical Solutions USA, Inc.

K-Number K162339

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PEW 2016-09-21

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge

Applicant Neotract, Inc.

K-Number K162345

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FLL 2016-09-21

Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

Applicant Nexmed Technology Co., Ltd.

K-Number K160816

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IYN 2016-09-21

E-CUBE 11

Applicant Alpinion Medical Systems Co., Ltd.

K-Number K161439

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