5 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
FDA Recall
Terminated
·C.L.R. Medicals International, Inc.·Product code LZP·November 25, 2013
Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
FDA Enforcement
Class I
·Terminated·C.L.R. Medicals International, Inc.·January 1, 2014
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code OEZ·December 20, 2018
MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.
FDA Recall
Terminated
·St. Jude Medical Cardiovascular Division·Product code DWS·January 26, 2011
Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.
FDA Recall
Terminated
·Laborie Medical Technologies Cor·Product code EXQ·April 9, 2009