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

NAY 2020-03-31

da Vinci X and Xi Surgical System

Applicant Intuitive Surgical, Inc.

K-Number K183086

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GEI 2020-03-31

Trigger Switch and Cord

Applicant New Deantronics Taiwan , Ltd.

K-Number K200455

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QKQ 2020-03-31

Sectra Digital Pathology Module

Applicant Sectra AB

K-Number K193054

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EZL 2020-03-31

AquaFlate Pre-Filled Sterile Water Syringe 10mL

Applicant H R Pharmaceuticals, Inc.

K-Number K200556

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PML 2020-03-31

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System

Applicant Stryker Corporation

K-Number K192818

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OUR 2020-03-31

SI-BONE iFuse Implant System®

Applicant SI-BONE, Inc.

K-Number K193524

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OWI 2020-03-31

The Gecko Spinal System

Applicant Ortho Development Corporation

K-Number K200281

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KGO 2020-03-31

Sterile Powder-Free Synthetic Rubber Surgeons Glove with Low Dermatitis Potential

Applicant Semperit Technische Produkte Gesellchaft M.B.H.

K-Number K191860

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MQV 2020-03-30

Agilon Strip

Applicant Biogennix, LLC

K-Number K193487

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NHA 2020-03-30

Universal Base Conical Connection (CC)

Applicant Nobel Biocare AG

K-Number K200040

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FTL 2020-03-30

T-Line Hernia Mesh

Applicant Deep Blue Medical Advances, Inc.

K-Number K193144

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MAX 2020-03-30

NuVasive Cohere Thoracolumbar Interbody System

Applicant Nu Vasive, Incorporated

K-Number K193541

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