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

GZT 2021-01-14

Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)

Applicant Vycor Medical, Inc.

K-Number K202694

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GEX 2021-01-14

OmniGuide BeamPath OTO-U Fiber

Applicant Omniguide, Inc.

K-Number K203241

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QKB 2021-01-14

ART-Plan

Applicant Therapanacea

K-Number K202700

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ODC 2021-01-14

BioGuard EUS Air/Water and Suction Valves

Applicant STERIS Corporation

K-Number K202104

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IYE 2021-01-14

Mobius3D

Applicant Varian Medical Systems, Inc.

K-Number K203669

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LRK 2021-01-14

Vital Sleep

Applicant The Snore Reliever Company, LLC

K-Number K201719

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EOB 2021-01-13

ENTity WiFi Video Nasopharyngoscope System

Applicant Optim, LLC

K-Number K200609

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HWC 2021-01-13

Inion CompressOn Screw

Applicant Inion OY

K-Number K203105

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HAW 2021-01-13

StealthStation Cranial Software v1.3.2

Applicant Medtronic Navigation, Inc.

K-Number K203639

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KPI 2021-01-13

MyOnyx System

Applicant Thought Technology , Ltd.

K-Number K201014

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OUR 2021-01-13

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

Applicant Medacta International S.A.

K-Number K203671

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FXX 2021-01-13

Procedure face mask (Model: KKF-2A)

Applicant Han Zhaoqing Sporting Goods Company Limited

K-Number K202314

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