7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
CLARUS CHOLANGIOGRAM CATHETER KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CLEARBLUE EASY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TURBIQUANT ASL
FDA 510(k)
FDA Class 1
·Microbiology
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 22, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
QUARTET
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 2014
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016