7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF
FDA 510(k)
FDA Class 2
·Cardiovascular
SHARPE ENDOHEMOSTAT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1
FDA 510(k)
FDA Class 2
·Hematology
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 13, 2014
SECURE ACUTE CARE BED 3/01
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 22, 2013
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code FPO·November 23, 2010
Single Lumen Central Venous 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