BEUDAMED
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    FDA UDI
    Omega Surgical Instruments Inc·00817438024245·3.6 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438024252·4.0 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438024207·2.0 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438024269·4.5 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438024214·2.4 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438024238·3.2 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438024191·1.6 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438024276·4.8 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438024221·2.8 MM X 125.0 MM STAINLESS STEEL TWIST BRILL B...

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    FDA UDI
    Omega Surgical Instruments Inc·00817438028618·2.1 MM X 200.0 MM SS TWIST DRILL BIT W/ STOP

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 18, 2020

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA classification
    FDA Class 3 ·Temporary Non-Roller Type Left Heart Support Blood Pump

    lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code OZD·September 4, 2019

    Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    Impella 5.5 Set AU; Product Code: 1000361;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    Pump 371 14F LT CMR Set; Product Code: 0048-0045;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    Impella CP Smart Assist Set, EU; Product Code: 0048-0014;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024

    Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·January 17, 2011

    Impella CP Smart Assist Set APAC; Product Code: 0048-0047;

    FDA Recall
    Open, Classified ·Abiomed, Inc.·Product code OZD·August 5, 2024