BEUDAMED
    4 results · 11ms · Sources: EU EUDAMED, US FDA

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    Filters Status: Terminated ×

    fastener, fixation, nondegradable, soft tissue

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU. Microlab AT+ and Microlab AT+2, part numbers 142000, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036

    FDA Recall
    Terminated ·Hamilton Co·Product code JTC·December 13, 2005

    PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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

    Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: Kinetra Model 7428 or Soletra Model 7426 Neurostimulator Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: Soletra Model 7426 Neurostimulator Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension Model 3387 or Model 3389 Lead.

    FDA Recall
    Terminated ·Medtronic Neuromodulation·Product code MHY·December 3, 2012