4 results
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35ms
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Sources: EU EUDAMED, US FDA
PACELINE, INC.
FDA registration
PACELINE, INC.·4 products·🇺🇸 United States
STEELEX ELEC 0 (3.5) 60CM HR26/GS65V
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code LDF·October 21, 2016
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·December 22, 2013
ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·February 5, 2014