3 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Advanced Bionics implantable cochlear stimulator HiRes 90, Models CI-1400-01 CI-1400-02
FDA Recall
Terminated
·Advanced Bionics·Product code MCM·September 27, 2004
PKG, 5MM X 45CM, INSERT, PERITONEAL SCISSORS, P/N 0250080751 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013