8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
EMIT THYROXINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPILLARYS IMMUNOTYPING, MODEL 2100
FDA 510(k)
FDA Class 2
·Immunology
Balanced Knee Revision System Trabecular Tibial Cone Augments
FDA 510(k)
FDA Class 2
·Orthopedic
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·March 13, 2018
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·April 30, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 11, 2012
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC (CINCINNATI)·Product code GDW·February 11, 2008
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025