7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
NITRATE REAGENTS A, B AND C
FDA 510(k)
FDA Class 1
·Microbiology
ENDO GIA RELOAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Exactech® Vantage® Total Ankle System
FDA 510(k)
FDA Class 2
·Orthopedic
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 28, 2013
ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 14, 2010
ACCESS ACCUTNI
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code MMI·July 12, 2014
THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
FDA Enforcement
Class II
·Ongoing·Therakos, Inc.·November 17, 2021