7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DYNATRON II
FDA 510(k)
FDA Class 2
·Orthopedic
LELECTIVE KINETIC SYSTEM-60
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AEVUMED PHANTOM Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2014
MAYFIELD MODIFIED SKULL CLAMP
FDA Adverse Event
Other
·INTEGRA-OHIO·Product code HBL·October 11, 2010
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER INC.·Product code MMI·December 19, 2012
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025