8 results
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25ms
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Sources: EU EUDAMED, US FDA
QUICKANCHOR (TM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WP Prosthetic Screw Noble Alloy
FDA UDI
STERNGOLD DENTAL LLC·00841549111488·Prosthetic Screws are intended for fixation of ...
PROTEMP II
FDA 510(k)
FDA Class 2
·Dental
BRONCHIAL CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REGENCY SC
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 22, 2010
BAERVELDT SHUNT
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code KYF·January 9, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 1, 2014
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017