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

OUW 2018-01-18

Nurture Rest

Applicant Neonatal Loving Kare, Inc.

K-Number K172962

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KPI 2018-01-18

Pelvifine Pelvic Muscle Trainer

Applicant Shenzhen Konmed Technology Co., Ltd.

K-Number K163288

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MLR 2018-01-18

AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

Applicant STERIS Corporation

K-Number K172319

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GEI 2018-01-17

ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes

Applicant Thermigen, L.L.C

K-Number K173582

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JWH 2018-01-17

Unity Total Knee System

Applicant Corin U.S.A. Limited

K-Number K173884

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OBJ 2018-01-17

OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)

Applicant Boston Scientific Corporation

K-Number K173820

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DYH 2018-01-17

OBA-MCP, Orthodontic Bracket Adhesive with MCP

Applicant Pulpdent Corporation

K-Number K173020

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DZJ 2018-01-17

PROPEL Device

Applicant Propel Orthodontics, LLC

K-Number K172164

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FLL 2018-01-17

Kinsa QuickCare Thermometer

Applicant Kinsa, Inc.

K-Number K173730

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PNN 2018-01-17

Ortho System

Applicant 3Shape A/S

K-Number K171634

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CDS 2018-01-17

epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

Applicant Epocal, Inc.

K-Number K171247

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FLL 2018-01-17

Medline Disposable Electronic Thermometer Probe Cover

Applicant Medline Industries, Inc.

K-Number K173113

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