11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MCSCP8PS WITH 'Y' HUB
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CODMAN® HOLTER®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780518037·CODMAN® HOLTER® Peritoneal Catheters Salmon Design
CODMAN HOLTER
FDA UDI
Cerenovus, Inc.·10886704040699·CODMAN HOLTER Peritoneal Catheter Salmon Design
NOVATION LPI PRIME FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
FDA 510(k)
FDA Class 2
·Dental
PERIT CATH BA SALMON 90CM
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·November 14, 2020
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
6000034-2012-01970
FDA Adverse Event
Injury
·COCHLEAR LTD·November 6, 2012
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·August 27, 2010
CERTAS INLIN VLV ONLY W/SPHNGD
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·November 14, 2020
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