8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
FDA 510(k)
FDA Class 2
·Neurology
Theracor
FDA 510(k)
FDA Unclassified
·Unknown
ALLOFIX ANCHOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2014
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·January 8, 2011
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026