9 results
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19ms
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Sources: EU EUDAMED, US FDA
ZEST MARK II (STANDARD & MINI)
FDA 510(k)
FDA Class 1
·Dental
JOBST Maternity
FDA UDI
BSN MEDICAL, INC.·04042809640533·OPAQUE MATERNITY 15-20 MM HG KNEE HIGH ZIG ZAG ...
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
FDA 510(k)
FDA Class 2
·Radiology
GLYCOSYLATED HEMOGLOBIN KIT
FDA 510(k)
FDA Class 2
·Hematology
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
ASKU
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·October 8, 2010
PCA EMPTY STERILE
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code MEA·November 28, 2012
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
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