8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MACCONKEY W/MUG
FDA 510(k)
FDA Class 1
·Microbiology
KLS Martin Cannulated Headless Screws
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ENDOCLIP
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GDO·April 25, 2014
VERSAPORT RT POWERSHIELD 5MM RAD CANNULA
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GCJ·October 1, 2010
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FPO·November 2, 2012
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
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012