BEUDAMED
    14 results · 16ms · Sources: EU EUDAMED, US FDA

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    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001

    FDA Recall
    Open, Classified ·Medtronic Inc·Product code DSQ·March 30, 2022

    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code MBF·February 21, 2023

    ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code JIS·March 8, 2022

    Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code DHA·November 24, 2022

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·March 18, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·March 18, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·March 18, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·March 18, 2025

    Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·March 18, 2025

    TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.

    FDA Recall
    Open, Classified ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code JDB·October 2, 2024

    Alinity hq Analyzer, REF: 09P68-01

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code GKZ·June 14, 2024

    Cub Pediatric Crib, Model FL19H

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FMS·February 18, 2026

    FISHER SCIENTIFIC Aseptic Control LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code MMS·May 25, 2022

    CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000

    FDA Recall
    Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FMS·May 12, 2021