10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
FDA 510(k)
FDA Class 2
·Cardiovascular
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 2, 2020
COMP RVS CNTRL 6.5X25MM ST/RST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 2, 2020
COMP PRIMARY STEM 10MM STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·January 2, 2020
PROPLATE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Athena 190
FDA 510(k)
FDA Class 1
·Physical Medicine
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 21, 2013
TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·August 1, 2014
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQC·August 5, 2015
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