7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GenNarino
FDA 510(k)
FDA Class 2
·Dental
COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
FDA 510(k)
FDA Class 2
·Neurology
CONSULTA CRT-D
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 7, 2010
RINGLOC LINER 28MM 10 DEG 24
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·December 6, 2012
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014