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

OLO 2018-11-02

NavLock Trackers, Robotic Reference Frame

Applicant Medtronic Navigation

K-Number K182104

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IYN 2018-11-02

Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System

Applicant Canon Medical Systems Corporation

K-Number K182596

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LZA 2018-11-02

Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff

Applicant Hartalega Sdn Bhd

K-Number K180786

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GEX 2018-11-02

Cellene CO2 Laser System

Applicant Bio-Med USA, Inc.

K-Number K182270

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OLO 2018-11-02

Mazor X System (Mazor X Stealth Edition)

Applicant Mazor Robotics , Ltd.

K-Number K182077

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NFJ 2018-11-02

Afina

Applicant Neurovision Imaging, LLC

K-Number K181501

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OLO 2018-11-02

CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K182121

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QDL 2018-11-02

Dexcom Pro Q Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K182405

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LZA 2018-11-02

Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs

Applicant Owens & Minor Halyard, Inc.

K-Number K182096

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HEB 2018-11-02

Interlude 100% Cotton Tampon

Applicant Albaad Fem

K-Number K181911

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OWB 2018-11-02

Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR

Applicant GE Healthcare

K-Number K181403

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DRY 2018-11-02

CDI Blood Parameter Monitoring System 550

Applicant Terumo Cardiovascular Systems Corporation

K-Number K182110

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