BEUDAMED
    181 results · 11ms · Sources: EU EUDAMED, US FDA

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    Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·March 26, 2014

    Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

    Colpo-Pneumo Occluder, Part CPO-6

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HEW·September 4, 2018

    Kit BD Max Check-Points CPO IVD EU; Catalog # 278102

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code N/A·July 17, 2019

    Colpo-Pneumo Occluder, Part CPO-6

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·October 17, 2018

    Kit BD Max Check-Points CPO IVD EU; Catalog # 278102

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

    FDA Recall
    Terminated ·LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel·Product code NBW·August 29, 2019

    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750009916, Software Product Code 6802864, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Unique Device Identifier Number 10758750001644, Software Version 2.8 and below, IVD. Product Usage: The VITROS 5,1 FS Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.).

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343, Software Version 3.2 and below; IVD. Product Usage: The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.)

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·November 3, 2015

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code GEY·September 25, 2018

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 19, 2013

    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 19, 2013

    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 19, 2013

    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 19, 2013

    Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 19, 2013

    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code CAC·November 19, 2013