8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COMBISCOPE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209110247·KIT, IFAK RESUPPLY - CUSTOM
Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
FDA 510(k)
FDA Class 2
·Cardiovascular
VELCRO SPLINT STRAP FASTENERS
FDA 510(k)
FDA Class 1
·Physical Medicine
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 4, 2010
PCA EMPTY STERILE
FDA Adverse Event
Malfunction
·HOSPIRA INC.·Product code MEA·November 27, 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