9 results
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21ms
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Sources: EU EUDAMED, US FDA
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
FDA 510(k)
FDA Class 2
·Radiology
Breathing circuit set, coaxial
FDA UDI
Hamilton Medical AG·07630002800921·Coaxial breathing circuit set with flow sensor ...
F3D Cervical Stand-Alone Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SPYSCOPE ACCESS & DELIVERY CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KOG·December 10, 2008
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC·Product code JJE·August 26, 2011
ARCHITECT IPTH
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code CEW·August 1, 2013
Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·November 4, 2015
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 12, 2018