6 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
FDA Recall
Terminated
·Wescam Inc·Product code REP·May 8, 2018
MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
FDA Enforcement
Class II
·Terminated·Wescam Inc·July 25, 2018
MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15 HDi. Long range surveillance, target designation.
FDA Recall
Terminated
·Wescam Inc
649 North Service Road West
Burlington Canada Ontario·Product code RET·August 1, 2009
WESCOM PATIENT STATION MODEL MEDLINK #SPS-3000
FDA Adverse Event
Malfunction
·CRITICAL ALERT, INC. - FORMERLY WESCOM·Product code ILQ·May 28, 2013
CRITICAL ALERT / INTEGO
FDA Adverse Event
Malfunction
·CRITICAL ALERT INC. (FORMERLY WESCOM)·Product code ILQ·April 13, 2017
PUMP MMT-1780KPK 670G PATHWAY BLACK MG
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·September 13, 2018