9 results
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18ms
·
Sources: EU EUDAMED, US FDA
EP-100 (SERIES)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST Travel Sock
FDA UDI
BSN MEDICAL, INC.·00035664013011·TRAVEL SOCKS 15-20 MM HG KNEE HIGH CLOSED TOE S...
Archon
FDA UDI
Nuvasive, Inc.·00887517078384·Archon Screw, 4.0x15mm Vari Self Tap
POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOMETRIAL PIPELLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code BTI·June 19, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 22, 2012
INFUSOR LV5, 12 PK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 28, 2010
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 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