7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OLYMPUS NBD TUBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SERVO VENTILATOR 900D SIEMENS-ELEMA AB
FDA 510(k)
FDA Class 2
·Anesthesiology
TRANSDUCER PROTECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 6, 2013
EASYTRAK
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code OJX·January 3, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 18, 2014
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013