8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ECAT SCANNER (MODEL 921)
FDA 510(k)
FDA Class 2
·Radiology
MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System
FDA 510(k)
FDA Class 2
·Radiology
ACTICHROME HEPARIN (ANTI-FIIA)
FDA 510(k)
FDA Class 2
·Hematology
MULTI SPECT 2 [510(K) K913630]
FDA Adverse Event
Other
·SIEMENS MEDICAL SYSTEMS·Product code IYX·April 13, 2001
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·November 12, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 3, 2014
PARIETEX UGYTEX PP ANTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·November 21, 2012
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015