BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    Rapicide PA High-Level Disinfectant Test Strips

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RUBICON 18 SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RADIUS-7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 2, 2015

    PERMANENT LIFE SUPPORT SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·October 3, 2014

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 7, 2013

    HS II PROXIMAL SEAL SYTEM 3.8MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DXC·June 24, 2011

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    PATIENT SAFETY NET

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code MSX·March 31, 2016

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·January 16, 2023

    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 Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024