8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Air Compression Therapy System
FDA 510(k)
FDA Class 2
·Physical Medicine
4MP COLOR LCD MONITOR, RADIFORCERX430
FDA 510(k)
FDA Class 2
·Radiology
FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ENDEAVOR
FDA Adverse Event
Malfunction
·MEDTRONIC VASCULAR·Product code NIQ·July 6, 2011
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 19, 2013
R SERIES ALS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·September 26, 2014
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018