7 results
·
31ms
·
Sources: EU EUDAMED, US FDA
ADVIA Centaur EBV-VCA IgM
FDA 510(k)
FDA Class 1
·Microbiology
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE ACL TIBIAL IMPLANT, VARIOUS CLASS I ANCILL
FDA 510(k)
FDA Class 2
·Orthopedic
ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PFCSIG FLUT FEMROD 5DG10X125MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC·Product code JWH·November 14, 2008
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 2, 2011
OT ULTRASMART METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2013
Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.
FDA Enforcement
Class II
·Terminated·Alcon Research Laboratories Ltd.·March 6, 2019