7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COAT-A-COUNT DHEA-SO4 RIA KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BIO-CORE INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
A7 Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORP·Product code FRN·February 21, 2014
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 21, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 12, 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