9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DANAM VECTOR-8+
FDA 510(k)
FDA Class 2
·Hematology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471121935·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 125mm
SEIDEL INTRAMEDULLARY PLUG
FDA 510(k)
FDA Class 2
·Orthopedic
PALINDROME P HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WEBSTER QUADROPOLAR - FIXED
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·June 26, 2012
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 10, 2014
NATURAL KNEE II CONGRUENT TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·October 26, 2010
33MM HEMORRHOID STAPLER 4.8MM STAPLES
FDA Adverse Event
Injury
·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES·Product code GDW·December 21, 2012
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012