9 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THE M100 AIR/OXYGEN MIXER
FDA 510(k)
FDA Class 2
·Anesthesiology
P.F.C.
FDA UDI
DEPUY (IRELAND)·10603295216018·P.F.C. MODULAR PLUS TIBIAL WEDGE STEP CEMENTED ...
COBAS 6000 SERIES SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Electric Wheelchair (DF506)
FDA 510(k)
FDA Class 2
·Physical Medicine
TORQUE WRENCH
FDA Adverse Event
Malfunction
·DEPUY SPINE INC·Product code HXC·February 7, 2020
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·November 5, 2012
EON 16-CHANNEL IPG
FDA Adverse Event
Malfunction
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·September 24, 2010
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