7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
TruLift Lateral Expandable Spacer System & Lateral Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
ECHELON LINEAR CUTTER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 20, 2014
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·November 6, 2012
HILL-ROM 100 LOW BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 26, 2010
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026