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

QDK 2019-10-25

Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System

Applicant Dexcom, Inc.

K-Number K192787

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LKO 2019-10-25

Maverick RNP Assay and Maverick Diagnostic System

Applicant Genalyte, Inc.

K-Number K191085

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BSO 2019-10-25

C-CAT Anaesthesia Catheter kit

Applicant Cimpax Aps

K-Number K191470

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IYN 2019-10-25

Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems

Applicant Supersonic Imagine

K-Number K191007

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KDJ 2019-10-25

MiniCap Extended Life PD Transfer Sets

Applicant Baxter Healthcare

K-Number K192705

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LIT 2019-10-24

Cronus HP PTA Balloon Catheter

Applicant Nipro Medical Corporation

K-Number K190037

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LPH 2019-10-24

Trident II Acetabular System

Applicant Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

K-Number K191358

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GEI 2019-10-24

Agnes

Applicant Agnes Medical Co., Ltd.

K-Number K192728

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OLO 2019-10-24

Zimmer Biomet Universal Navigation System

Applicant Zimmer Biomet Spine, Inc.

K-Number K190556

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BWF 2019-10-24

Acapella Choice Blue Vibratory PEP Device

Applicant Smiths Medical

K-Number K181660

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PKL 2019-10-24

Padlock Clip defect closure system, Padlock Pro-Select defect closure device

Applicant STERIS Corporation

K-Number K192722

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IYE 2019-10-24

MU2net

Applicant Dosisoft

K-Number K191944

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