BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    JAGWIRE HIGH PERFORMANCE GUIDWIRE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331154133·moleskin & felt scissors, sharp/blunt points, 7...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L141820120·14mm H x 18mm W x 20mm L XLIF Trial 12 degree L...

    TALOS®-A

    FDA UDI
    SpineArt SA·07640375237798·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D26 ...

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321418200·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311418200·

    SOLO-CARE AQUA ANTIMICROBIAL LENS CASE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 4, 2014

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 28, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 27, 2011

    RING TRANSJUGULAR INTRAHEPATIC ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·November 15, 2019

    CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012