8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak
FDA 510(k)
FDA Class 2
·Cardiovascular
BUTTON AID W/POCKET CLIP, BK-2011
FDA 510(k)
FDA Class 1
·Physical Medicine
RESERVOIR, CASSETTE, 100ML, FS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·September 5, 2018
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 21, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 26, 2012
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 19, 2010
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025