7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
BIOTIS UREA AGAR
FDA 510(k)
FDA Class 1
·Microbiology
SV600, SV800 Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
ERG-JET ELECTRODE
FDA 510(k)
FDA Class 1
·Ophthalmic
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·October 26, 2012
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·June 2, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·September 21, 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