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

KHE 2017-06-14

hema-screen SPECIFIC Gold

Applicant Immunostics Inc.,

K-Number K171484

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HRS 2017-06-14

EVOS Small Fragment Lower Extremity Plates

Applicant Smith & Nephew, Inc.

K-Number K170457

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IYN 2017-06-14

Vivid S60N, Vivid S70N

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K170878

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LLZ 2017-06-14

EchoPAC Software Only, EchoPAC Plug-in

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K170847

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FCG 2017-06-14

Howell Biliary Introducer Needle

Applicant Wilson-Cook Medical, Inc.

K-Number K160890

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DXN 2017-06-14

TONOPORT VI

Applicant Par Medizintechnik GmbH & Co. KG

K-Number K170966

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NAY 2017-06-13

da Vinci Xi Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K170713

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PKT 2017-06-13

Sculpsure

Applicant Cynosure, Inc.

K-Number K171111

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ILY 2017-06-13

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System

Applicant Healthlight, LLC

K-Number K163079

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OTD 2017-06-13

Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette

Applicant Medtronic Vascular, Inc.

K-Number K171427

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NAY 2017-06-13

da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree

Applicant Intuitive Surgical, Inc.

K-Number K171426

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MAX 2017-06-13

FUSE Spinal System

Applicant Medtronic Sofamor Danek

K-Number K171468

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