7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PY-CO-PROX TM DENTAL BRUSH
FDA 510(k)
FDA Class 1
·Dental
CYFRA 21-1 EIA MODEL 211-10
FDA 510(k)
FDA Class 2
·Immunology
STAT-SHELL DISPOSABLE SP02 SENSOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COMP LK SCR 3.5HEX 4.75X20 ST
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·May 8, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 18, 2012
S-ROM LINER LSER, 20DEG, 28MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·August 10, 2010
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