10 results
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17ms
·
Sources: EU EUDAMED, US FDA
MICROFLUOR B REMOVAWELL STRIPS
FDA 510(k)
FDA Class 1
·Microbiology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788229620·Tranquil-L ALIF Trial 16x32x25, 12 deg
WIENER LAB. BILIRRUBINA TOTAL AA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CHEM-ASSAY STANDARD-CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
G7 ACETABULAR SYSTEM DUAL MOBILITY ACETABULAR LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 28, 2017
XLD 110V L.A. REF
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 19, 2014
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 7, 2012
POWERLINK SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·September 1, 2010
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014
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