7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
RESIL
FDA 510(k)
FDA Class 2
·Dental
CORCAM HEART MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 30, 2014
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 20, 2012
SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GDW·June 12, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018