11 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFIED STOCKERT-SHILEY VENOUS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PAEDIATRIC CANNULA, VENOUS
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWF·June 7, 2023
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOMET CC CRUCIATE TRAY 75MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 22, 2017
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 24, 2014
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 29, 2010
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./ HUNTINGTON·Product code HQL·December 21, 2012
M2A-MAGNUM MOD HD SZ 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 12, 2018
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·November 12, 2018
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