8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
AMERLITE MAB FT4 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COMPAT ENTERAL DELIVERY SYSTEMS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICRO-AIRE MODEL NUMBER: MK-426
FDA 510(k)
FDA Class 2
·Neurology
IMPELLA 5.5
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·November 12, 2025
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 11, 2013
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011
VISCOELASTIC CANNULA
FDA Adverse Event
Injury
·HURRICANE MEDICAL·Product code HMX·July 23, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021