9 results
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26ms
·
Sources: EU EUDAMED, US FDA
IL TEST PHENYTOIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
P.F.C.
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295215882·P.F.C. MODULAR PLUS HEMI WEDGE TRIAL SZ 4 20 DEG
Dynamo Spinal Cement; Salvo® Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
SCD EXPRESS SLEEVE K/L MEDIUM
FDA Adverse Event
Other
·COVIDIEN·Product code JOW·November 27, 2012
NOVA MAX GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORPORATION·Product code NBW·September 23, 2010
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012