8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RETIC-SET
FDA 510(k)
FDA Class 1
·Hematology
POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
IOGYN SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 30, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 21, 2012
VOYAGER RX CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code LOX·September 21, 2010
PULSE GENERATOR, PERMANENT, IMPLANTABLE
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NVZ·September 22, 2017
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