7 results
·
23ms
·
Sources: EU EUDAMED, US FDA
BANDAGE, UNIPRESS, CLARION
FDA 510(k)
FDA Class 1
·General Hospital
ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO ARTHROCARE ARTHROWANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 13, 2007
ADAPTA SR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·October 3, 2012
OPTI-FREE EVERMOIST
FDA Adverse Event
Injury
·ALCON - FORT WORTH/ ALCON LABORATORIES, INC.·Product code LPN·December 19, 2013
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015