8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BRIGHAM TIBIAL CEMENT PRESSURIZER
FDA 510(k)
FDA Class 1
·Orthopedic
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
FDA 510(k)
FDA Class 2
·Dental
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
FDA 510(k)
FDA Class 2
·Orthopedic
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 27, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 27, 2014
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·November 12, 2012
CRYSTALENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code NAA·September 10, 2010
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015