9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HIgH-Flo Super26 Subcutaneous Needle Sets
FDA 510(k)
FDA Class 2
·General Hospital
ALEUTIAN SPACER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ABREU, MODEL 700
FDA 510(k)
FDA Class 2
·General Hospital
ARTERIAL PRESSURE MONITORING TRAY
FDA Adverse Event
Malfunction
·COOK INC·Product code DQO·December 3, 2024
SYNCHRO2-14 SUPPORT STRAIGHT 215CM
FDA Adverse Event
Malfunction
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023
CIC PRO CLINICAL INFORMATION CENTER
FDA Adverse Event
Death
·GE HEALTHCARE·Product code DSI·July 21, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·June 20, 2013
MAVERICK2 MONORAIL PTCA CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code LOX·September 23, 2008
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