7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
YD STRIP GLUCOSE U19
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LITHOTOMY CHAIR #415
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IRRIGATION/ASPIRATION KIT
FDA 510(k)
FDA Class 2
·Ophthalmic
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·November 15, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
2015691-2010-14055
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·September 15, 2010
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019