7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OverStitch Endoscopic Suturing System and Accessories
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMBOCARE 2000
FDA 510(k)
FDA Class 2
·Neurology
SEILER COLPOSCOPE, MODELS 935, 955 AND 985
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 21, 2013
JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·July 8, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·September 30, 2008
SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
FDA Enforcement
Class II
·Terminated·SenTec AG·August 14, 2019