BEUDAMED
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    T2CandidaCartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida species in EDTA human whole blood specimens.

    FDA Recall
    Terminated ·Product code PII·July 7, 2016

    Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty

    FDA Recall
    Terminated ·Product code JWH·January 11, 2016

    I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·October 11, 2013

    Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA for use in total knee arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.

    FDA Enforcement
    Class II ·Terminated·Picis Inc.·August 7, 2013

    I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST

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

    AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code MEA·October 27, 2005

    AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code MEA·December 21, 2005

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Enforcement
    Class II ·Terminated·Water Pik, Inc.·August 15, 2018

    Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty

    FDA Recall
    Terminated ·Product code JWH·January 11, 2016

    STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FRC·April 22, 2013

    Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IXR·October 21, 2004

    MultiDiagnost MD4

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    LithoDiagnost

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    Diagnost 96/97 DSI

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    UroDiagnost

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    MultiDiagnost MD3

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    EasyDiagnost

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009

    Easy Diagnost Digital

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code JAA·July 6, 2009