10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
GENESIS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
FDA 510(k)
FDA Class 2
·General Hospital
Stryker Orthopaedics Hip Systems Labeling Update
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO·Product code DTB·February 9, 2013
EDWARDS MC3 TRICUSPID ANNULOPLASTY RING
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code KRH·January 8, 2011
SUPERFLEX ASPHERIC
FDA Adverse Event
Injury
·RAYNER INTRAOCULAR LENSES LIMITED·Product code HQL·July 18, 2014
DRIVING CAP/THREADED
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code LXH·October 28, 2016
1.5MM SYSTEM 4 HOLE LONG STRAIGHT PLATE
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·December 12, 2017
DRIVING CAP/THREADED
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·July 13, 2023
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026