13 results
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20ms
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Sources: EU EUDAMED, US FDA
RERMCO TEST CHLORIDE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788231060·Lateral Angle Curette #2 Ang Right
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435060991·MCD Screw 2.3 x 6 mm M1
lockin...
Ditron Dental
FDA UDI
DITRON DENTAL LTD·07290109283784·Mini Ti-Base Cylindrical Non-Engaged H0.6
PROMOTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
FDA 510(k)
FDA Class 2
·Radiology
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD 8010379·Product code JDI·January 5, 2015
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD 8010379·Product code JDI·January 5, 2015
UNKNOWN DEPUY STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·February 19, 2015
THUNDERBEAT 5MM 10CM INLINE GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·January 20, 2014
STRATUS® CS STAT FLUOROMETRIC ANALYZER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code JHX·November 7, 2012
PRESEP - CENTRAL VENOUS OXIMETRY CATHETER KIT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DQE·September 1, 2010
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