7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SOFFBAN ORTHOPEDIC PADDING
FDA 510(k)
FDA Class 1
·Physical Medicine
UNIMARK HOME PREGNANCY TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TI STAR IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2014
GAMMA 3 NAIL
FDA Adverse Event
Injury
·STRYKER TRAUMA GMBH·Product code JDS·October 30, 2012
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·June 10, 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