7 results
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18ms
·
Sources: EU EUDAMED, US FDA
WALLSTENT ESOPHAGEAL PROSTHESIS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITREA IMAGE DENOISING SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·February 3, 2013
54CM BIPOLAR LEAD
FDA Adverse Event
Injury
·GREATBATCH MEDICAL·Product code DTB·December 20, 2010
PROMUS PREMIER?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 17, 2014
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