9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ECAT PRT
FDA 510(k)
FDA Class 2
·Radiology
EMCO WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
AEQUALIS REVERSED SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
AEQ REVERSED II GLENOID SPHERE D.42MM CENTER D 25MMBASEPLATE
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code PHX·October 2, 2024
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON-HOUSTON·Product code LRO·December 17, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 17, 2014
S8 COMPACT - AMERICAS
FDA Adverse Event
Malfunction
·RESMED LTD.·Product code BZD·December 20, 2012
AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POST
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·January 7, 2025
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