9 results
·
35ms
·
Sources: EU EUDAMED, US FDA
CONPHAR BLOOD PRESSURE CUFFS
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUSS THORACOLUMBAR PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Panthera Dental Milled Bars
FDA 510(k)
FDA Class 2
·Dental
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 6, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 12, 2012
HOMECHOICE, DOMESTIC 120V
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SAO PAULO·Product code FKX·August 10, 2010
BD ALARIS¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025