9 results
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22ms
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Sources: EU EUDAMED, US FDA
POC ENT ENDOSCOPE - SINUSCOPE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983123·posteriors; shade D4; size L; lower jaw
MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
microTargeting Guideline 4000 5.0 System
FDA 510(k)
FDA Class 2
·Neurology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 25, 2014
ADAPTER SLEEVES 12/14 +2
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 28, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 31, 2011
Philips Zenition 70, Model Number: 718133
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024
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