12 results
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21ms
·
Sources: EU EUDAMED, US FDA
NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
Armada
FDA UDI
Nuvasive, Inc.·00887517394460·ARM16S Screw, 4.5x40mm Fixed
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665583246·MIS Cannulated Screw, Ø4.5 x 40mm, Ø6.0mm Rod
VIDEO SYSTEM INTERFACE MODELS
FDA 510(k)
FDA Class 2
·Radiology
PLAK VAK - PV-10
FDA 510(k)
FDA Class 1
·Dental
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 29, 2014
BA102
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·March 31, 2016
BA105
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·March 28, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·August 29, 2017
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017