28 results
·
28ms
·
Sources: EU EUDAMED, US FDA
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
FDA 510(k)
FDA Class 2
·General Hospital
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221045614·Unitek(TM) Molar Band General Purpose Wide Regu...
PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
CYTORI CELUTION CELL CONCENTRATION DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·July 5, 2018
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Death
·ETHICON INC.·Product code GAW·July 5, 2018
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Death
·ETHICON INC.·Product code GAW·July 5, 2018
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Death
·ETHICON INC.·Product code GAW·July 5, 2018
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
SMALL CLIP APPLIER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2013
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·July 1, 2011
XENIUM DIALYZER
FDA Adverse Event
Injury
·NIPRO CORPORATION·Product code KDI·September 12, 2008
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
ADVANCED PATELLA 35MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 9, 2024