108 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Radiology
Sklar
FDA UDI
SKLAR CORPORATION·10649111451942·ROCH-CARMALT FCP CVD 10 INCHES
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BONALIVE GRANULES
FDA 510(k)
FDA Class 2
·Orthopedic
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·February 13, 2020
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·December 15, 2021
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·February 9, 2022
CRESCENT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code MAX·April 11, 2022
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MAX·November 16, 2018
PERFORMER INTRODUCER
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 4, 2022
CRESCENT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code MAX·November 13, 2018
CAPSTONE PTC SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·July 8, 2020
CRESCENT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code MAX·December 7, 2017
CRESCENT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code MAX·April 1, 2020
CRESCENT SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code MAX·October 11, 2021
CRESCENT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code MAX·March 22, 2019
CRESCENT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MSD DEGGENDORF MFG·Product code MAX·January 7, 2019
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·July 1, 2011
INTRAVASCULAR SHUNT
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DWF·June 14, 2013