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

MUJ 2016-02-16

Radiance V3

Applicant Gmv Soluciones Globales Internet S.A.U.

K-Number K153368

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DSY 2016-02-16

FUSION Vascular Graft

Applicant Maquet Cardiovascular, LLC

K-Number K153523

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LOX 2016-02-16

FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm

Applicant Ostial Corporation

K-Number K152485

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OLO 2016-02-16

TSolution One w/ACG+ Surgical System

Applicant THINK Surgical, Inc.

K-Number K153647

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NKG 2016-02-16

Zimmer Virage OCT Spinal Fixation System

Applicant Zimmer Spine, Inc.

K-Number K153631

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NKG 2016-02-16

Caspian OCT/MESA Mini/DENALI Mini Spinal System

Applicant K2m, Incorporated

K-Number K153370

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NQQ 2016-02-16

NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

Applicant Ninepoint Medical, Inc.

K-Number K153479

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BSK 2016-02-16

AnapnoGuard 100 Respiratory Guard System

Applicant Hospitech Respiration , Ltd.

K-Number K150157

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KNW 2016-02-15

Intact® Gen2 System

Applicant Intact Medical Corporation

K-Number K152596

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OLP 2016-02-15

Clear Bi-Light

Applicant Michael Todd, LP

K-Number K153081

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MWI 2016-02-14

Star 60

Applicant Skanray Technologies Private Limited

K-Number K151512

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ITI 2016-02-12

WHILL Model M

Applicant Whill, Inc.

K-Number K153543

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