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

CCK 2019-02-06

CO2 Sampling Line

Applicant Tylenol Medical Instruments Co., Ltd.

K-Number K181981

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MAX 2019-02-06

Omnia Medical Rotary PLIF System

Applicant Omnia Medical, LLC

K-Number K183659

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OUR 2019-02-06

SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments

Applicant Globus Medical, Inc.

K-Number K183119

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PQK 2019-02-06

WavelinQ 4F EndoAVF System

Applicant C.R. Bard, Inc.

K-Number K182796

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EOB 2019-02-06

RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4

Applicant Olympus Medical Systems Corp.

K-Number K182102

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KWQ 2019-02-06

Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System, Premier Anterior Cervical Plate, Venture Anterior Cervical Plate, Zephir Anterior Cervical Plate System and Zevo Anterior Cervical Plate System

Applicant Medtronic Sofamor Danek USA, Inc.

K-Number K182885

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LPL 2019-02-06

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives

Applicant Alcon Laboratories, Inc.

K-Number K190045

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GDW 2019-02-06

Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black

Applicant Ethicon Endo-Surgery, LLC

K-Number K183435

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MRD 2019-02-05

Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

Applicant Motiva USA, LLC

K-Number K183163

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LKN 2019-02-05

Spectra Optia Apheresis System

Applicant Terumobct, Inc.

K-Number K183081

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HSB 2019-02-05

PRECICE® BONE TRANSPORT System

Applicant Nuvasive Specialized Orthopedics, Inc.

K-Number K182170

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IZL 2019-02-05

JADE Mobile X-Ray

Applicant DRGEM Corporation

K-Number K183388

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