17 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CenterCross Ultra Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
FDA 510(k)
FDA Class 2
·Neurology
ADVIA CHEMISTRY GLUH_3 REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 10, 2013
WIRE COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 30, 2011
HS HAND CONTROLLED CURVED SHEA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·September 5, 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
MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·August 11, 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