7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
FALL-SAFE MONITOR
FDA 510(k)
FDA Class 1
·General Hospital
IMAGENMD
FDA 510(k)
FDA Class 2
·Radiology
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
FDA 510(k)
FDA Class 2
·Radiology
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 24, 2012
SPECTRANETICS GLIDELIGHT LASER SHEATH
FDA Adverse Event
Death
·SPECTRANETICS CORPORTATION·Product code MFA·May 30, 2014
TORAY IV SET
FDA Adverse Event
Malfunction
·Product code FPA·September 22, 2010
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