8 results
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36ms
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Sources: EU EUDAMED, US FDA
MagVenture TMS Therapy System
FDA 510(k)
FDA Class 2
·Neurology
ChartCheck
FDA 510(k)
FDA Class 2
·Radiology
RCRP Flex reagent cartridge
FDA 510(k)
FDA Class 2
·Immunology
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 14, 2014
ACTIVA SC
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·September 8, 2011
UNICEL® DXC 800 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·July 29, 2013
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021