17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
FDA 510(k)
FDA Class 2
·Radiology
priti®multidisc ZrO2
FDA UDI
Pritidenta GmbH·04251366905188·
Tizian Blank 5.0
FDA UDI
Pritidenta GmbH·04251366906222·
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 24, 2025
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
FDA 510(k)
FDA Class 2
·Microbiology
AERONEB PRO
FDA 510(k)
FDA Class 2
·Anesthesiology
QT SCANNER 2000 MODEL A
FDA Adverse Event
Injury
·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·August 23, 2011
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 3, 2014
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 3, 2013
ANN PH NAIL RT 9X160MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·July 24, 2025
ANN BLUNT TIP SCREW 4X54MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·July 24, 2025
ANN BLUNT TIP SCREW 4X50MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·July 24, 2025
ANN BLUNT TIP SCREW 4X48MM
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code HSB·July 24, 2025
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025