13 results
·
27ms
·
Sources: EU EUDAMED, US FDA
T-TUBE DRAIN, ROUND
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
REAGENT, RIA TRIIODOTHYRONINE T3 (#200)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·September 9, 2024
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·April 8, 2014
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·September 26, 2012
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·July 19, 2010
VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version)
FDA Recall
Terminated
·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·December 17, 2007
VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version)
FDA Recall
Terminated
·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·December 17, 2007
VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version)
FDA Recall
Terminated
·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·December 17, 2007
VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version)
FDA Recall
Terminated
·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·December 17, 2007
VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version)
FDA Recall
Terminated
·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·December 17, 2007
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025