8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
FETAL BOVINE SERUM IN TRANSFER CONTAINER
FDA 510(k)
FDA Class 1
·Hematology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209120406·
BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VibraPEP
FDA 510(k)
FDA Class 2
·Anesthesiology
SYMBIQ DUALCHAN INF
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·April 4, 2014
HEARTMATE II LVAS
FDA Adverse Event
Injury
·SYNCARDIA CARDIOWEST·Product code DSQ·November 30, 2012
DUROM US ACETABULAR COMPONENT 50/44 J
FDA Adverse Event
Malfunction
·ZIMMER GMBH·Product code KWA·September 27, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024