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

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    Pressure Monitoring Set, C-PMS, G02838

    FDA Recall
    Terminated ·Cook Inc.·Product code DQY·April 30, 2020

    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

    FDA Recall
    Completed ·Cook Incorporated·Product code DQY·May 25, 2022

    The product is an isolation transformer, an accessory to Computed Tomography Scanner. It consists of electronic circuitry enclosed in a metal case. According to Philips Medical Systems, the metal case is manufactured from self-extinguishing materials. The unit is labeled in part, "Power Conditioner *** Part Number 4450028-XX *** Frequency: *** S/N: *** Rev: *** MFG date: *** INPUT RATINGS *** Model: MCT 100/480 ISOTRAN PLUS *** OUTPUT RATINGS *** MEDICAL POWER SUPPLY UL *** TEAL Electronics Corporation, San Diego, California ***".

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·April 27, 2007

    REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

    FDA Recall
    Terminated ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code LPH·October 1, 2021

    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

    FDA Recall
    Terminated ·Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy·Product code LPH·October 1, 2021

    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

    STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·February 25, 2008

    STERRAD NX Sterilizer, Product Code 10033 Used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·February 25, 2008

    STERRAD 200 Sterilization System, Product Code 10201 Used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·February 25, 2008

    STERRAD 100S Sterilization System, Product Code 10101 Used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·February 25, 2008

    STERRAD 100NX Sterilizer, Product Code 10104 Used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·February 25, 2008