10 results
·
141ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFIED CALCITONIN RIA KIT DSL #1200
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GC Initial™
FDA UDI
Gc America Inc.·15400556704186·GC Initial™ AL Inside IN-42 Terracota, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228740871·GC Initial™ Ti Enamel Occlusal EO-17, 20g
XANAR MODEL XSE-300 SMOKE EVACULATER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL XLE
FDA 510(k)
FDA Class 2
·Radiology
ENDURANCE BONE CEMENT 20G
FDA Adverse Event
Injury
·DEPUY CMW ¿ REG. # 9610921·Product code LOD·June 16, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 19, 2010
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 14, 2012
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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
PM 1260 ASSURITY + 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