8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
FDA 510(k)
FDA Class 2
·Immunology
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIEMENS ULTRATHERM 708
FDA 510(k)
FDA Class 2
·Physical Medicine
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
CONSULTA
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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