8 results
·
23ms
·
Sources: EU EUDAMED, US FDA
GILFORD C4 COMPLEMENT REAGENT
FDA 510(k)
FDA Class 2
·Immunology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209119837·
NESS L300
FDA 510(k)
FDA Class 2
·Neurology
ACC-U-THERM TEMPERATURE MONITOR
FDA 510(k)
FDA Class 2
·General Hospital
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 4, 2014
OUTBACK RE-ENTRY CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DQY·November 30, 2012
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·September 28, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024