7 results
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33ms
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Sources: EU EUDAMED, US FDA
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC
FDA 510(k)
FDA Class 1
·Radiology
TRANSLUMINAL ENDARTERECTOMY DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
T-PAL SMALL TRIAL IMPLANT SIZ 9 NON DETA
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MAX·February 6, 2013
IBT EXPRESS
FDA Adverse Event
Malfunction
·KYPHON NEUCHATEL·Product code HRX·July 18, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 3, 2011
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