9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NEXUS ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
Pyramesh® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978080918·MESH 905-408 PYRM 10 X 14 OVOID X 8MM
PYRAMESH® Implant System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000856441·MESH 905-408 PYRM 10 X 14 OVOID X 8MM
THE TONGUE BRUSH
FDA 510(k)
FDA Class 1
·Dental
FACTOR VIII DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 19, 2010
QUARTET
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 9, 2013
EASYTRAK 2
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NIK·July 1, 2014
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024