BEUDAMED
    18 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.

    FDA Enforcement
    Class II ·Terminated·Paa Laboratories Inc·July 24, 2013

    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsuccessful disk surgery - Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions - Peripheral causalgia - Epidural fibrosis - Arachnoiditis or lumbar adhesive arachnoiditis - Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·November 6, 2013

    Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back; Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk; Post laminectomy pain; Multiple back operations; Unsuccessful disk surgery; Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions; Peripheral causalgia; Epidural fibrosis; Arachnoiditis or lumbar adhesive arachnoiditis; Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·July 25, 2018

    Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back; Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk; Post laminectomy pain; Multiple back operations; Unsuccessful disk surgery; Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions; Peripheral causalgia; Epidural fibrosis; Arachnoiditis or lumbar adhesive arachnoiditis; Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia.

    FDA Enforcement
    Class II ·Terminated·Medtronic Neuromodulation·July 25, 2018

    Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 6, 2016

    CBS micro, countersink, cannulated, AO, Item Number ST503004541

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS high, countersink, cannulated, AO, Item Number ST503004542

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS high, countersink, cannulated, AO, Item Number 503004542

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS 7.5 tap, cannulated, AO, Item Number 503002041

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS micro, countersink, cannulated, AO, Item Number 503004541

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS micro, countersink, cannulated, round-shaft, Item Number 503004341

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS high, countersink, cannulated, round-shaft, Item Number 503004342

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351

    FDA Enforcement
    Class II ·Terminated·Zimmer GmbH·May 29, 2019

    Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation

    FDA Enforcement
    Class II ·Terminated·Zimmer Gmbh·May 24, 2017

    TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

    FDA Enforcement
    Class II ·Terminated·Zimmer Gmbh·August 10, 2016

    Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.

    FDA Enforcement
    Class II ·Terminated·FMS, Finapres Medical Systems BV·August 15, 2012