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

LNH 2019-03-15

Vantage Galan 3T, MRT-3020/A9, V5.0

Applicant Canon Medical Systems Corporation

K-Number K183657

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KPI 2019-03-15

ApexMV

Applicant Incontrol Medical, LLC

K-Number K182022

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IZL 2019-03-15

MOBILETT Elara Max

Applicant Siemens Medi Cal Solutions, Inc.

K-Number K182639

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IYN 2019-03-15

FUJIFILM Sonosite Vevo MD Imaging System

Applicant FUJIFILM Sonosite, Inc.

K-Number K190476

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NUH 2019-03-15

HIVOX OTC Electrical Stimulator

Applicant Hivox Biotek, Inc.

K-Number K190347

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HEB 2019-03-15

COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT

Applicant Cotton High Tech S.L.

K-Number K182813

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LHI 2019-03-15

nextaro Transfer System, nextaro va

Applicant Sfm Medical Devices GmbH

K-Number K183187

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JWH 2019-03-15

Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly

Applicant Total Joint Orthopedics, Inc.

K-Number K190280

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GKZ 2019-03-15

CELL-DYN Emerald 22 AL System

Applicant Abbott Laboratories

K-Number K190294

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DQY 2019-03-15

SelectSite C304-HIS Deflectable Catheter System

Applicant Medtronic, Inc.

K-Number K183493

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KCT 2019-03-15

TCAT (R) THA Instrument Tray Set

Applicant THINK Surgical, Inc.

K-Number K180127

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FJL 2019-03-15

Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch

Applicant Corinth Medtech, Inc.

K-Number K190099

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