30 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PHILIPS MONITOR R-061282 INTELLIVUE MX750
FDA Adverse Event
Other
·PHILIPS NORTH AMERICA LLC·Product code MHX·February 26, 2024
AIW WATER SYSTEM FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LV-1 HEMOSTASIS VALVE, MODEL #6789
FDA 510(k)
FDA Class 2
·Cardiovascular
TSRH® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 19, 2013
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC ORTHOPEDIC INC.·Product code KWP·December 4, 2009
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·December 4, 2009
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 29, 2013
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 13, 2022
MINIMAL ACCESS ATTACHMENT, BLACK MAX
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBE·April 10, 2013
CRYSTALENS
FDA Adverse Event
Injury
·EYEONICS, INC.·Product code HQL·June 16, 2008
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWP·April 12, 2011
TSRH SPINAL SYSTEM
FDA Adverse Event
WARSAW ORTHOPEDIC, INC.·Product code KWP·August 26, 2011
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 14, 2017
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 11, 2023
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 5, 2022
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 8, 2022
BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·July 6, 2022
BD ALARIS SMARTSITE NEEDLE-FREE VALVE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 8, 2023