BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ARSENAL PETITE LAPIDUS PLATE, R

    FDA Adverse Event
    Injury ·TRILLIANT SURGICAL·Product code HRS·April 3, 2020

    C-PORT - HP POWER INJECTABLE PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ISSYS LP SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013

    SECNDRY SET 34IN NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPK·July 25, 2011

    PERFORMA JUDKINS RIGHT CATHETER

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·September 26, 2008

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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