8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
FDA 510(k)
FDA Class 2
·General Hospital
BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIM·February 11, 2013
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·July 24, 2014
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 30, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024