17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surefire Infusion System
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....
FEMVUE CORNUAL BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ADAPTIVE WEDGE
FDA 510(k)
FDA Class 2
·Orthopedic
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 10, 2013
TPS CONSOLE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HWE·June 30, 2011
CONTOUR NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024