10 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pathway
FDA UDI
SPINAL ELEMENTS·00840916129545·Pathway ELIF Small 8mm
BD ULTRASAFE PLUNGER ROD
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·December 20, 2022
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·March 31, 2016
MI VARNISH
FDA 510(k)
FDA Class 2
·Dental
ADVIA IMS CARBAMAZEPINE METHOD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PFC OFFSET TIB TRAY RM/LL S4
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 23, 2011
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 3, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·September 23, 2014
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021