11 results
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27ms
·
Sources: EU EUDAMED, US FDA
ORTHORALIX SD/ORTHORALIX SD CEPH
FDA 510(k)
FDA Class 2
·Radiology
ReLine
FDA UDI
Nuvasive, Inc.·00195377035455·RELINE-C Bender Tip, Ø3.5 Ang Sag Left
Cramer AT Pro Tape
FDA UDI
HYGENIC CORPORATION, THE·00311960003216·Cramer AT Pro Tape, White 1.5" x 15 yards Sampl...
FORZA
FDA UDI
Orthofix US LLC·18257200077588·CUP CURETTE STRAIGHT #00- SMOOTH
Site Seal SV
FDA 510(k)
FDA Class 2
·Cardiovascular
RHEUMATELL
FDA 510(k)
FDA Class 2
·Immunology
GIALLOY CB/N-H
FDA UDI
SRL Dental GmbH·ESRL58903511·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 11, 2014
COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 3, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·December 29, 2012
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012