10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
BOWEN PROBE
FDA 510(k)
FDA Class 1
·Orthopedic
VisualEyes
FDA 510(k)
FDA Class 2
·Neurology
ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
FDA 510(k)
FDA Class 2
·Dental
FOLYSIL CATHETER
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·May 15, 2020
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 10, 2014
SECURA VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 9, 2010
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·December 10, 2012
CR TIBIAL INSERT SZ4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 23, 2023
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
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022