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

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    BioBrace ® RC Delivery System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776183455·Mini Lambotte Osteotome str

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780434054·Integra® Jarit® Lambotte Mini Osteotome, Straight

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464090716·OTICON JET 2 BTE C091

    IMPEDIMED - BODY COMPOSITION ANALYSIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Omega LIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 14, 2021

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 28, 2024

    CRYSTALENS [TM]

    FDA Adverse Event
    Injury ·BAUSCH & LOMB SURGICAL·Product code HQL·December 3, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    BIOGLIDE® PERITONEAL CATHETER 8 SLITS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·July 26, 2013

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024