7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT
FDA 510(k)
FDA Class 2
·Dental
UCA CREAM PRODUCT REFORMULATION
FDA 510(k)
FDA Class 2
·Neurology
U-Blade Veress Needle
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·December 10, 2012
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL MANUFACTURING CORPORATION·Product code MVK·June 18, 2015
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020