BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYNAMIC COMPRESSION SMA Staple System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074051444·STAPLE 8162103 3MM X 9MM TWO PRONG SMA

    Mouthpiece, Disposable Flex, 3/4" OD, 2.625" L

    FDA UDI
    A-M SYSTEMS, LLC·00817081023534·Mouthpiece, Disposable Flex, 3/4" OD, 2.625" L

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989054095·PRLS 2NDMOL B/T 12DEG -10T 022 NDX UL

    KERRISON PUNCH RONGEUR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896018280·KERRISON PUNCH RONGEUR UP-ANGLE TIP

    DARCO FORCE TITANIUM COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SKELETAL DYNAMICS STERILIZATION TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 6, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2011

    ROTABLATOR GUIDE WIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MCX·September 16, 2008

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Death ·SOPHYSA·Product code GWM·November 18, 2024

    SOEHENDRA STENT RETRIEVER

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code FGE·September 26, 2017

    C-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 24, 2020

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    PRESSIO ICP AND ICT MONITORING KIT, PARENCHYMAL WITH BOLT

    FDA Adverse Event
    Malfunction ·SOPHYSA·Product code GWM·November 18, 2024

    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