8 results
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18ms
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Sources: EU EUDAMED, US FDA
MUREX SUDS RUBELLA
FDA 510(k)
FDA Class 2
·Microbiology
PREMIER® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074229287·PLATE 6861282 82.5MM FSP ANTERIOR CRV
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
FDA 510(k)
FDA Class 2
·Neurology
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
PDS II (POLYDIOXANONE) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code NEW·October 1, 2010
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 2012
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