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 2016-09-21

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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LLZ 2016-09-21

CAAS MRV

Applicant Pie Medical Imaging BV

K-Number K162112

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GEX 2016-09-21

Sterling 5W Diode Laser

Applicant CAO Group, Inc.

K-Number K160413

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FMI 2016-09-21

CPL Insulin Pen Needle

Applicant Cpl Co., Ltd.

K-Number K151090

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NRY 2016-09-21

Solitaire Platinum Revascularization Device

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K-Number K161879

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DTZ 2016-09-21

Affinity NT Oxygenator with Cortiva BioActive Surface

Applicant Medtronic, Inc.

K-Number K162016

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NKG 2016-09-21

QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments

Applicant Globus Medical, Inc.

K-Number K161591

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HRS 2016-09-21

ARIX Hand System

Applicant Jeil Medical Corporation

K-Number K161746

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BZD 2016-09-20

F&P Eson 2 Nasal Mask

Applicant Fisher & Paykel Healthcare Limited

K-Number K153505

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