7 results
·
32ms
·
Sources: EU EUDAMED, US FDA
EMIT AUTO DIGOXIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Echelon Endopath Staple Line Reinforcement
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
E-STATIS 40 SYSTEM
FDA 510(k)
FDA Class 1
·Dental
UNIFY ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·May 5, 2014
EXTERNAL PULSE GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 22, 2015
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018