3 results
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7ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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PKG, MIXTER FORCEPS, P/N 0250080249. 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
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of the Ball Tip Guide Wires for Smooth Tip Guide Wires: T2 Tibial Nailing Systems, T2 Femoral Nailing Systems, T2 Ankle Nailing Systems, and T2 Humerus Nailing Systems
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·February 5, 2014
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015