8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
POLAROID TPX RADIOGRAPHIC FILM
FDA 510(k)
FDA Class 1
·Radiology
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
TALON DISTALFIX PROXIMAL FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
GORE® EXCLUDER® AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·May 15, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·August 17, 2010
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
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025