5 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·July 22, 2015
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
Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System Component: 32x54 Acetabular Bearing, Catalog: 01-02-3254, 32x56 Acetabular Bearing, Catalog: 01-02-3256, Femoral Head Resurfacing Component, BP Hip System Component: 36.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0036, 38mm Femoral Head Resurfacing Component:, Catalog: 01-03-0038, 39.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0039, 41mm Femoral Head Resurfacing Component:, Catalog: 01-03-0041, 42.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0042, 44mm Femoral Head Resurfacing Component:, Catalog: 01-03-0044, 45.5mm Femoral Head Resurfacing Component:, Catalog: 01-03-0045, 47mm Femoral Head Resurfacing Component:, Catalog: 01-03-0047, 49mm Femoral Head Resurfacing Component:, Catalog: 01-03-0049, 51mm Femoral Head Resurfacing Component:, Catalog: 01-03-0051, 52mm Femoral Head Resurfacing Component:, Catalog: 01-03-0052. Femoral Stem BP Hip System Component: 10mm Femoral Stem Catalog: 01-04-0110, 11mm Femoral Stem Catalog: 01-04-0111, 12mm Femoral Stem Catalog: 01-04-0112.
FDA Recall
Terminated
·Endotec, Inc.·Product code JWH·June 5, 2009
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
FDA Enforcement
Class II
·Terminated·Primus Corporation·November 11, 2020
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·March 31, 2021