30 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VIPER SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
FDA 510(k)
FDA Class 2
·Anesthesiology
OMNIPOD 5 POD
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·June 1, 2023
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 3, 2023
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Death
·INSULET CORPORATION·Product code LZG·July 19, 2023
ONE TOUCH ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·October 22, 2008
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JGS·August 5, 2011
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·December 13, 2023
OMNIPOD DASH, PODS 10-PACK
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 9, 2023
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021
OMNIPOD INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·January 23, 2024
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code LZG·July 21, 2022
V.A.C. GRANUFOAM DRESSING
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·June 4, 2021
OMNIPOD 5 POD
FDA Adverse Event
Injury
·INSULET CORPORATION·Product code QFG·July 11, 2023
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·September 3, 2020
ACTIV.A.C. THERAPY SYSTEM
FDA Adverse Event
Malfunction
·KINETIC CONCEPTS, INC.·Product code OMP·June 11, 2020