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

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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DZE 2017-06-13

Deep Conical (DC) Implants and Accessories

Applicant Southern Implants (Pty), Ltd.

K-Number K163060

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MQG 2017-06-13

COOK Vacuum Pump

Applicant William A. Cook Australia Pty. , Ltd.

K-Number K160753

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GEI 2017-06-13

SECRET RF

Applicant Ilooda Co,., Ltd.

K-Number K170325

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LOX 2017-06-12

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

Applicant B. Braun Interventional Systems, Inc.

K-Number K162625

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MAX 2017-06-12

SPIRA Open Matrix ALIF

Applicant Camber Spine Technologies

K-Number K162986

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