10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
FDA 510(k)
FDA Class 2
·Immunology
AGILIS ES STEERABLE INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
AMISTEM H COATED LAT STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 25, 2021
JETSTREAM SC
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·May 29, 2013
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·August 22, 2008
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·June 18, 2011
LINER: CC E CC LIGHT FLAT PE HC Ø 32 / F
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 25, 2022
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023