8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ORTHOPHOS 5/PLUS/CD
FDA 510(k)
FDA Class 2
·Dental
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983057·posteriors; shade B3; size XL; lower jaw
I-MAX TOUCH
FDA 510(k)
FDA Class 2
·Dental
PUMA-G System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PWRD ECH FLEX 60MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 28, 2013
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·February 4, 2011
CERTAIN® ZIREAL® POST 4.1(D) X 5(P) X 4(H) W/ZIREAL® HEXED SCREWS
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NHA·August 6, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024