15 results
·
39ms
·
Sources: EU EUDAMED, US FDA
ENDO-SECURE
FDA 510(k)
FDA Class 1
·Anesthesiology
LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CC
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXCATH ADVANCE STEERABLE SHEATH
FDA Adverse Event
Injury
·MEDTRONIC CRYOCATH LP·Product code DRA·September 30, 2014
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·August 10, 2013
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NIK·August 10, 2013
ENRHYTHM
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·August 9, 2013
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVZ·August 9, 2013
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·November 20, 2012
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code ILS·May 30, 2014
VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·September 22, 2010
GORE® ACUSEAL VASCULAR GRAFT
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·June 29, 2022
GORE® ACUSEAL VASCULAR GRAFT
FDA Adverse Event
Malfunction
·W. L. GORE & ASSOCIATES, INC.·Product code DSY·June 29, 2022
ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 21, 2019
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024