7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
FDA 510(k)
FDA Class 2
·Immunology
Accutension Smartphone Auscultatory Blood
FDA 510(k)
FDA Class 2
·Cardiovascular
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 5, 2012
UNKNOWN STRYKER TIBIAL COMPONENT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·July 26, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025