10 results
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26ms
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Sources: EU EUDAMED, US FDA
BIOPSY FORCEPS W/OVAL CUP & NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERLING
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975063915·
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC
FDA 510(k)
FDA Class 2
·General Hospital
DIMENSION TPSA CALIBRATOR, MODEL #RC459
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PARADYM 2
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L. - CRM FACILITY·Product code MRM·May 20, 2014
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 6, 2012
X8000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·August 27, 2010
PAEDIATRIC CANNULA, VENOUS
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWF·June 7, 2023
OEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024
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