10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NIDEK MODEL AKC-8000
FDA 510(k)
FDA Class 2
·Ophthalmic
AUTORANGING DIGITAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SILICONE OIL 350 CNETISTOKE
FDA 510(k)
FDA Class 2
·Cardiovascular
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code LPL·August 3, 2012
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·July 19, 2012
STOCKERT CENTRIFUGAL PUMP CONSOLE
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DTQ·June 19, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 3, 2013
CLINAC
FDA Adverse Event
Malfunction
·VARIAN MEDICAL SYSTEMS·Product code IYE·November 4, 2010
DAILIES TOTAL 1
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·November 9, 2012
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
FDA Recall
Terminated
·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code KWQ·November 22, 2011