8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
Sasmar Melon
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008310·PERSONAL LUBRICANT
URINARY CATHETERIZATION SYSTEM W/O FOLEY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CATSmart
FDA 510(k)
FDA Class 2
·Anesthesiology
LOCKING BLUNT CANNULA 11 GAUGE
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·May 29, 2014
PUMP MMT-722LNAB PRDGM INS BL EN ML
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code LZG·October 19, 2010
ELEVATE APICAL AND POSTERIOR
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 13, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025