8 results
·
30ms
·
Sources: EU EUDAMED, US FDA
ACA PLUS FREE THYROXINE(FT4) METHOD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
DEPUY INTERNATIONAL LTD·10603295243281·CUP MATRIX PHANTOM - 47MM CUP
BAND-AID(R) BRAND LIQUID BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
NovoPen Echo
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·February 14, 2013
NEXGEN CR-FLEX GSF FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·July 15, 2014
LUCAS 2
FDA Adverse Event
Death
·JOLIFE·Product code DRM·January 12, 2011
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