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

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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KGO 2021-01-13

Polyisoprene Powder Free, Black Colour Surgical Gloves

Applicant Emerson & Co. Srl

K-Number K192933

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DZE 2021-01-13

BEGO Semados® RS/RSX Implant System

Applicant Bego Implant Systems GmbH & Co. KG

K-Number K201700

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OVE 2021-01-12

NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System

Applicant Precision Spine, Inc.

K-Number K203129

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FXX 2021-01-12

Disposable Medical Surgical Mask

Applicant Tianjin Saiyuan Technology Co., Ltd.

K-Number K201625

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JAK 2021-01-12

Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i

Applicant Canon Medical Systems Corporation

K-Number K201836

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