8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ESTRIOL RADIOIMMUNOASSAY TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NA
FDA UDI
Zimmer, Inc.·00889024273887·
BIPOLAR HF DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KOALA CLAMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CAMINO ADVANCED MONITOR WITH ICP WAVEFORM
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES, LTD.·Product code GWM·March 21, 2014
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
CE INTERMATE LV 50, 24 PACK, 50126
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 23, 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