7 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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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
Guardian Services, Part Number 0240-009-430 with Part Numbers: 0240-030-004 and/or 0240-030-002, 0240-030-008 (Net Practice). The intended us of Guardian is to act as a medical data backup and disaster recovery plan.
FDA Recall
Terminated
·Stryker Imaging·Product code LMB·July 31, 2009
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
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012