7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER
FDA 510(k)
FDA Class 2
·Hematology
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SERUM GLUTAMIC-PYRUVIC TRANSAMINASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
OVATIO
FDA Adverse Event
Injury
·SORIN CRM S.A.S.·Product code MRM·October 22, 2010
SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Injury
·DEXCOM INC.·Product code MDS·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