8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PULMONEX DYNAMIC AIR THERAPY UNIT
FDA 510(k)
FDA Class 2
·Physical Medicine
SKIPPER AND SKIPPER RACE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro well group culture dish, 9-well; Micro well group culture dish, 16-well
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCESSORIES
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·June 9, 2014
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·February 8, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020