8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INFLUENZA A ANTIGEN TEST
FDA 510(k)
FDA Class 1
·Microbiology
K042172
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022
CLEO 90 INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
LIGHTMED TRUSCAN 577
FDA 510(k)
FDA Class 2
·Ophthalmic
RESTORE SENSOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·November 30, 2010
ALTRX +4 10D 36IDX62OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 4, 2013
ACTIVA
FDA Adverse Event
Malfunction
·NEURO - VILLALBA·Product code MHY·July 17, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015