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

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    WishBone Medical Plate and Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113509·MINIATURE BLADE #67 (BX/5)

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 8, 2020

    HCP DICOM NET

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHASE CARDIOVASCULAR PATCH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSURE Z NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    TOTAL ASR FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 2, 2013

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·December 23, 2022

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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