8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COAGULASE PLASMA
FDA 510(k)
FDA Class 1
·Microbiology
B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP.·Product code MZI·January 15, 2014
BEYONDIMAGE WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
AEON Laparoscopic Instruments
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 13, 2014
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 10, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 10, 2010
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