9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZEISS 30 SL-L
FDA 510(k)
FDA Class 2
·Ophthalmic
K2-HF OPAQUER powder, O-A3,5 20g.
FDA UDI
Yeti Dentalprodukte GmbH·EYET38620040·
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190622·Sizing Guide 3 deg Rotation Bushing -1mm
PREMIUM Implant Systems SHELTA Implant Systems
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 22, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·October 31, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·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