7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LEONE IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BIOSCANNER TRIGLYCERIDES TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PALAMED BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
EASYPUMP II ST 100-0, 5-S
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL PRODUCTION LTD.·Product code MEB·March 13, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 15, 2011
TENDRIL SDX
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008
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