9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MULTISET 40
FDA 510(k)
FDA Class 2
·General Hospital
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209118861·
Stainless Steel Wire
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746047565·WIRE SS LOWER 019 X 025 FORM II 10/PK
Perla Posterior Cervico-Thoracic Fixation system
FDA 510(k)
FDA Class 2
·Orthopedic
XLTEK EMU40 EEG HEADBOX, MODEL PK1072
FDA 510(k)
FDA Class 2
·Neurology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·November 30, 2012
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·September 27, 2010
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