BEUDAMED
    15 results · 24ms · Sources: EU EUDAMED, US FDA

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    Metallic Fabric Electrodes

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA UDI
    Synthes GmbH·10886982144447·3.0MM CANNULATED SCREW SHORT THREAD/36MM

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2026360·3.0mm, Cannulated Screw, Short Thd., 36mm

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF2026360·3.0mm Cannulated Screw, Short Thread, 36mm

    BODY BOX 5500

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZENITH PEDICLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 30, 2025

    UNKNOWN LIGASURE INSTRUMENT

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GEI·May 14, 2026

    G7 STR MONOBLOCK SHELL INSRTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LXH·April 10, 2018

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN MANUFACTURING·Product code FJI·September 18, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·August 11, 2011

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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