8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Radical the Dude 8F Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
VenAir, Sequential Compression System
FDA 510(k)
FDA Class 2
·Cardiovascular
XW-100 Automated Hematology Analyzer, XW QC CHECK
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 11, 2014
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·August 19, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 23, 2013
Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and probes.
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code GXI·October 29, 2013