8 results
·
35ms
·
Sources: EU EUDAMED, US FDA
TURBO
FDA 510(k)
FDA Class 2
·Physical Medicine
MammoScreen
FDA 510(k)
FDA Class 2
·Radiology
RENAL GUIDING SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 21, 2020
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON - BELGIUM/ ALCON N.V.·Product code KYG·May 14, 2014
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·December 2, 2010
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 30, 2012
Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
FDA Recall
Terminated
·Terumo Medical Corporation·Product code DYB·June 24, 2010