7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TOILET/SHOWER CHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
FDA 510(k)
FDA Class 2
·Dental
CPS-1000
FDA 510(k)
FDA Class 2
·Cardiovascular
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 20, 2014
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·December 10, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021