9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TICARCILLIN 75MCG. SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
MOBICATH TRANSSEPTAL NEEDLE
FDA 510(k)
FDA Class 2
·Cardiovascular
Sentimag System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLUM A+ DRIVER NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 7, 2014
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 7, 2012
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2015
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 5, 2024
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015
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