8 results
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19ms
·
Sources: EU EUDAMED, US FDA
SECA LIGHT WEIGHT BABY SCALE 744
FDA 510(k)
FDA Class 1
·General Hospital
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR28220421·Betaflex wires Titanium Straight-Arch-F. max. ....
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC)
FDA 510(k)
FDA Class 2
·Cardiovascular
ENTERALITE INFINITY ENTERAL FEEDING PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code LZH·October 9, 2012
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 20, 2014
MONOPOLAR CABLE W/LG PIN, 10 FEET
FDA Adverse Event
Malfunction
·KIRWAN SURGICAL PRODUCTS, INC.·Product code GEI·August 27, 2010
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