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

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    KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

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

    VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT

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

    RPL/CPL VERTICAL PLATFORM LIFTS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·June 27, 2013

    SYMBIQ

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code FRN·March 24, 2011

    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,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024