7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CHLAMYDIA OVERBY MEDIA
FDA 510(k)
FDA Class 1
·Hematology
INOMAX DSIR (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
AEROMIST LT, MODEL HCS15004
FDA 510(k)
FDA Class 2
·Anesthesiology
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 26, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 14, 2012
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code LFL·September 12, 2007
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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