8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ARCHIMEDES Biodegradable Pancreatic Stent
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADROIT Guiding Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO: VIEWSTATION
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
MINICAP TRANSFER
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 12, 2011
LIGAMAX CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 11, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 23, 2013
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·May 18, 2016