8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MICROTECH BACTERIAL CONTROLS
FDA 510(k)
FDA Class 1
·Microbiology
Tranquil-L™
FDA UDI
NEXUS SPINE, L.L.C.·B6788229540·Slim Straight Handle
AMEDICA DRUG SCREEN COCAINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001
FDA 510(k)
FDA Class 2
·Orthopedic
UNK
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 19, 2014
SYSTEM 1E
FDA Adverse Event
Malfunction
·STERIS CORPORATION·Product code JOJ·October 25, 2012
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 1, 2010
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