13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
FDA 510(k)
FDA Class 2
·Cardiovascular
LAPAROSCOPIC CATHERTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INNOFLUOR(TM) DIGITOXIN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 14, 2016
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 31, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 6, 2021
MONARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code OTN·February 12, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 18, 2011
ONE TOUCH LANCING DEVICE
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 29, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 6, 2012
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·April 9, 2014
TSH, THYROTROPIN
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·March 24, 2014
FT4, FREE THYROXINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CEC·February 20, 2014