8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GLOMARK
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NA
FDA UDI
LANCER ORTHODONTICS, INC.·00817573024247·REVERSE PULL FACE MASK-ADJUSTABLE 1/PK
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VIVORTE BVF
FDA 510(k)
FDA Class 2
·Orthopedic
NEURON DELIVERY CATHETER 053
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·March 15, 2010
SMARTSKIN LASER SYSTEM
FDA Adverse Event
Injury
·CYNOSURE, INC.·Product code GEX·May 5, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 13, 2012
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