BEUDAMED
    19 results · 18ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO THE GRIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890105260·Zirlux Multi-Unit Abutment 3 mmH compatible wit...

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964150692·Endo Carry-on Procedure Kit contains Basins, In...

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163191·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163221·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163238·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163245·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163184·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163207·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033163214·

    Intess C

    FDA UDI
    Kalitec Direct LLC·B07309K0100260·Assembly, Caddie, Implants, Hinged

    EMBOGOLD MICROSPHERE

    FDA 510(k)
    FDA Class 2 ·Neurology

    HARDYDISK, CEPHALOTHIN 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LAMITRODE TRIOPOLE 16

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 14, 2013

    NEXGEN MIS STEMMED TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·March 1, 2011

    6949 SPRINT FEDELIS ICD LEAD

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC. CARDIAC RHYTHM MANAGEMENT·Product code LWS·February 5, 2008

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015