10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BECKMAN BETA-2-MICROGLOBULIN (B2M)
FDA 510(k)
FDA Class 2
·Immunology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074087818·INSTRUMENT 2940353 12MM SHAVER
VARIAX
FDA UDI
Stryker GmbH·07613327177268·Small Fragment Tray Clip
STARBAND AND STARLIGHT
FDA 510(k)
FDA Class 2
·Neurology
FLIGHT SOCK
FDA 510(k)
FDA Class 2
·General Hospital
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 17, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·December 20, 2010
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·November 14, 2019
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020