11 results
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20ms
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Sources: EU EUDAMED, US FDA
PRO-SPEC
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FAC-3 - Class B 21 Lawson - 3 Shelf Cabinet
FDA UDI
Certified Safety Manufacturing, Inc.·00766588620848·FAC-3 - Class B 21 Lawson - 3 Shelf Cabinet
INTRODUCER SET, MODEL ADELANTE-S SERIES
FDA 510(k)
FDA Class 2
·Cardiovascular
ATLAS MONITOR, MODELS 200,210,220
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·April 7, 2022
TREVO XP PROVUE RETRIEVER 4X20
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·May 20, 2014
LUMAX 540 DR-T
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code MRM·October 9, 2012
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·August 22, 2010
SAFESHEATH II 9F
FDA Adverse Event
Malfunction
·OSCOR INC.·Product code DYB·August 10, 2022
BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·April 27, 2022
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