9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
truFreeze System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAGEMAX Z-BLANK
FDA 510(k)
FDA Class 2
·Dental
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC.·Product code LIT·June 19, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·February 14, 2013
TRIATHLON-PRIM TIB BASEPLATE CEMENTED #2
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·January 10, 2011
CER BIOLOXD OPTION HD 36MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LZO·November 22, 2021
CER OPTION TYPE 1 TPR SLEVE +6
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code LZO·November 22, 2021
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