8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
GRID/RADIOGRAPHIC
FDA 510(k)
FDA Class 1
·Radiology
MTS Ciprofloxacin 0.002 - 32 µg/mL
FDA 510(k)
FDA Class 2
·Microbiology
INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
6461500 INFUSOR PUMP (1 LABEL)
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 11, 2010
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 19, 2014
ACTIVE CORD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·October 26, 2010
MATRIX POLYAXIAL SCREW
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·December 21, 2012
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025