14 results
·
20ms
·
Sources: EU EUDAMED, US FDA
UPHOLSTERED BUCKET SEAT
FDA 510(k)
FDA Class 1
·Physical Medicine
PrismaSATE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
FDA 510(k)
FDA Class 2
·Cardiovascular
G2 FILTER SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 21, 2007
RECOVERY G2 FILTER SYSTEM, FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 23, 2007
G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·August 19, 2010
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 20, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 9, 2010
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·December 10, 2012
RECOVERY G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·February 5, 2010
RECOVERY G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·September 15, 2009
G2 FILTER SYSTEM
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·September 21, 2007
RECOVERY G2 FILTER SYSTEM, FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 27, 2007
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021