BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    CEDIA DAU AMPHETAMINES/ECSTASY ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Vivid NuFill Unit Dose Bleach

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724D0104960·20x .25g

    Ovation

    FDA UDI
    Ortho Development Corporation·00822409121274·Narrow Stem Size 10.5 STD

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163450·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163436·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163429·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163443·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163405·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163467·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163412·

    INSET I

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 1, 2025

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 9, 2026

    EVERSHEARS BIPOLAR SCISSORS

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

    A.V. FISTULA NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ALIGN TO URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·March 14, 2013

    SHILEY LOW PRESSURE CUFFED

    FDA Adverse Event
    Injury ·COVIDIEN/ FORMERLY TYCO·Product code JOH·March 1, 2011

    MEDEX

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL·Product code FMG·February 7, 2008

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019