7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
FDA 510(k)
FDA Class 2
·Hematology
MODEL 2100 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Q-Pad Test System
FDA 510(k)
FDA Class 2
·Hematology
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 14, 2014
REPAIR CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·December 8, 2010
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 28, 2012
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