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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.
FDA Recall
Terminated
·Bausch and Lomb, Incorporated·Product code NAA·November 14, 2011
Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly.
FDA Recall
Terminated
·Ortho Development Corporation·Product code LZO·January 11, 2011
Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle Component: Size 2 Talar Component Catalog: 05-01-0002, Size 3 Talar Component Catalog: 05-01-0003, Size 4 Talar Component Catalog: 05-01-0004, Size 5 Talar Component Catalog: 05-01-0005, BP Ankle System, Thick Talar Ankle Component: Size 2 Thick Talar Component Catalog: 05-11-0002, Size 3 Thick Talar Component Catalog: 05-11-0003, Size 5 Thick Talar Component Catalog: 05-11-0005, B-P Ankle System, Tibial Component: Size 2 Tibial Component 05-03-0002, Size 3 Tibial Component 05-03-0003, Size 4 Tibial Component 05-03-0004, Size 5 Tibial Component 05-03-0005,
FDA Recall
Terminated
·Endotec, Inc.·Product code JWH·June 5, 2009
Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·January 9, 2013
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016