12 results
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18ms
·
Sources: EU EUDAMED, US FDA
NPG 2 BASE METAL ALLOY
FDA 510(k)
FDA Class 1
·Dental
C-DAK 2100 ARTIFICIAL KIDNEY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DXE·November 27, 2024
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES PR·Product code DXE·February 4, 2026
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·June 24, 2014
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 3, 2010
DEXTRUS 4135
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·December 18, 2012
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXE·March 13, 2025
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DXE·September 5, 2025
FOGARTY
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DXE·February 11, 2025
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024