8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PORTABLE GASEOUS OXGYEN CONTAINER
FDA 510(k)
FDA Class 1
·Anesthesiology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209110292·KIT, TORK w/ CG - ODG - CUSTOM
Bladeless Optical Obturators
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INO THERAPEUTICS INOBLENDER, MODEL 10004
FDA 510(k)
FDA Class 2
·Anesthesiology
OT PING ENHANCED METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
CONTAK RENEWAL
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 4, 2010
STAMMBERGER SINU-FOAM NASAL DRESSING
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code LYA·November 14, 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