9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NA
FDA UDI
STERILMED, INC.·10888551007535·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007528·SAW BLADE SAGITTAL K9 K2000 SERIES
Ancora Nerve Block Catheter Set
FDA 510(k)
FDA Class 2
·Anesthesiology
ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·November 1, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014
ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DENTSPLY PROFESSIONAL·Product code EKX·November 28, 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