7 results
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32ms
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Sources: EU EUDAMED, US FDA
HIPPURATE HYDROLYSIS TEST
FDA 510(k)
FDA Class 1
·Microbiology
JULIET® LL Lateral Lumbar Cage
FDA 510(k)
FDA Class 2
·Orthopedic
HANDPIECE, DENTAL
FDA 510(k)
FDA Class 1
·Dental
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·October 31, 2012
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·November 7, 2013
BMT 360 SM CRUCIATE AUG TRL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 23, 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