9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZAVATION
FDA UDI
Zavation LLC·00842166152427·WHITNEY 14mmx16mm , 7deg , 12mm
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
FDA 510(k)
FDA Class 2
·Neurology
FORA COMFORTSCAN EAR THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
QUALICHECK, LEVEL 1
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code GIO·April 5, 2013
S-ROM*SLEEVE PRX ZTT, 18D-LRG
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code MRA·January 17, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
VERITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013