8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BLOOD PRESSURE, DIGITAL MODEL #2153
FDA 510(k)
FDA Class 2
·Cardiovascular
VESSEL-CLUDE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DENTAL OFFICE ENVIRONMENT CONTROL UNIT
FDA 510(k)
FDA Class 1
·Dental
ELLIPSE DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·April 30, 2014
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012
PULSAR MAX II
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code NVZ·August 3, 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