7 results
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19ms
·
Sources: EU EUDAMED, US FDA
CORE-SNARE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ULTIMA TENS XL-A1
FDA 510(k)
FDA Class 2
·Neurology
TRANSPORT CULTURE MEDIUM DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
PERCUTANEOUS CATHETER INSERTION TRAY WITH 8 FRENCH INTRODUCER
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYB·October 28, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 23, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·May 28, 2014