9 results
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35ms
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Sources: EU EUDAMED, US FDA
SERALYZER HEMOGLOBIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Hematology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR28220461·Betaflex wires Titanium Straight-Arch-F. max. ....
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
FDA 510(k)
FDA Class 2
·Hematology
WRIST PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023
ILLINOIS (TJ) NEEDLE, ASPIRATION, 18G
FDA Adverse Event
Injury
·CAREFUSION·Product code KNW·April 5, 2010
HARMONIC ACE CURVED SHEARS INSERT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 20, 2014
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·November 7, 2012
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