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

DXH 2019-05-10

Triangle System

Applicant AliveCor, Inc.

K-Number K183319

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HEB 2019-05-09

Unscented Menstrual Tampon

Applicant Qingdao Youjia Hygiene Technology Co., Ltd.

K-Number K190218

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KCT 2019-05-09

DePuy Synthes Sterilization Container System

Applicant Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

K-Number K181933

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IOR 2019-05-09

Rowheels Revolution 1.0

Applicant Rowheels, Inc.

K-Number K190699

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JPA 2019-05-09

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge

Applicant Haemonetics Corporation

K-Number K183160

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LZO 2019-05-09

Delta Dual Mobility System

Applicant Lima Corporate S.P.A.

K-Number K181491

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PDQ 2019-05-09

ATEC IOM Accessory Instruments

Applicant Alphatec Spine, Inc.

K-Number K182617

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DQY 2019-05-09

Wingman 14C Crossing Catheter

Applicant Reflow Medical, Inc.

K-Number K190393

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MLR 2019-05-09

V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems

Applicant STERIS Corporation

K-Number K190917

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DXN 2019-05-09

TOF-Cuff monitor

Applicant Rgb Medical Devices SA

K-Number K181894

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ORY 2019-05-09

Encore System

Applicant Siesta Medical, Inc.

K-Number K183310

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NXC 2019-05-09

Magic Clear Aligners

Applicant Voodoo Manufacturing, Inc.

K-Number K190948

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