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

OMD 2020-06-05

Exofin Fusion Skin Closure System

Applicant Chemence Medical, Inc.

K-Number K191461

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CHL 2020-06-05

epoc Blood Analysis System

Applicant Epocal, Inc.

K-Number K200107

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LZA 2020-06-05

Latex Examination Powder Free Glove, Aloe Vera

Applicant Top Glove Sdn. Bhd.

K-Number K193150

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ITX 2020-06-05

EZ-Cover

Applicant Medxpress.Pro

K-Number K191491

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QHE 2020-06-05

Signature ONE System

Applicant Orthosoft Inc (D/B/A Zimmer Cas)

K-Number K200615

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PNN 2020-06-05

NemoCast

Applicant Software Nemotec S.L.

K-Number K193003

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ETD 2020-06-05

Hummingbird Tympanostomy Tube System

Applicant Preceptis Medical, Inc.

K-Number K200952

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JIN 2020-06-05

VivaChek Blood Glucose and B-Ketone Monitoring System

Applicant Vivachek Biotech (Hangzhou) Co., Ltd.

K-Number K192957

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MSX 2020-06-05

Spire Health Remote Patient Monitoring System

Applicant Spire, Inc. D/B/A Spire Health

K-Number K192952

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QFG 2020-06-04

t:slim X2 Insulin Pump with Interoperable Technology

Applicant Tandem Diabetes Care, Inc.

K-Number K201214

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KWQ 2020-06-04

CarboClear® Cervical Plate System

Applicant CarboFix Orthopedics , Ltd.

K-Number K200883

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JWH 2020-06-04

Journey II XR Knee Instrument

Applicant Smith & Nephew, Inc.

K-Number K200227

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