9 results · 26ms · Sources: EU EUDAMED, US FDA

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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