8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209110391·KIT, IFAK - SOLO - CUSTOM
KD-322 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
FD TENS 2090, FD TENS 2095
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010
EVAC 70 XTRA PLASMA WAND
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·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