12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·January 18, 2019
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2019
BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQO·November 26, 2025
MICROSHEATH XL CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
ORION MICRO CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VIEWFLEX XTRA ICE CATHETER
FDA Adverse Event
Malfunction
·STERILMED, INC.·Product code OWQ·July 7, 2022
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 17, 2013
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 23, 2011
EQUATE DENTURE ADHESIVE
FDA Adverse Event
Injury
·SHEFFIELD PHARMACEUTICALS·Product code KOQ·September 26, 2014
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 10, 2025
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