11 results
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19ms
·
Sources: EU EUDAMED, US FDA
DESERET ARTERIAL BLOOD SAMPLING KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
Tranquil-C™
FDA UDI
NEXUS SPINE, L.L.C.·B6788222480·Cervical Rasp 6x16x14
HERCULITE XRV
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EBF·August 22, 2014
IGROW II HAIR GROWTH SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
STRYKER L3 HYDROLERT
FDA 510(k)
FDA Class 2
·General Hospital
SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·December 30, 2016
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
PFC*SIGMA/OV/DOME PAT 3PEG,38
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code JWH·November 7, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 5, 2015
SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·March 20, 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