BEUDAMED
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    PERMANENT LEAD INTRADUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right

    Elite Orthopaedics

    FDA UDI
    Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left

    Helix

    FDA UDI
    Nuvasive, Inc.·00887517136022·Helix R Plate, 56mm 3-Level

    0800,APS1,08,N,VL,IW

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828144926·0800,APS1,08,N,VL,IW

    C.T.M. MOBILITY SCOOTER, MODEL H2-686, HS-740, HS-580

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TDS PRECISION DENTAL BAR

    FDA 510(k)
    FDA Class 2 ·Dental

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Malfunction ·LIMACORPORATE SPA·Product code HSD·September 10, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 22, 2012

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code NBW·September 28, 2007

    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FRN·September 24, 2013

    NicVue Software version 2.9.2 and 3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is intended to be the patient database for various Nicolet applications. The NicVue software is intended to aid the hospital in tracking patient data from collection to review to archive. The NicVue Software includes the following features and intended uses: Launch Applications, Enter patient information, Import/Export patient information from the Hospital Information System, Move data files, Archive data files on DVD or CDROM.

    FDA Recall
    Terminated ·CareFusion 209 Inc.·Product code OUG·December 16, 2011

    ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FGE·November 7, 2008

    ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FGE·November 7, 2008

    ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Used for drainage of bile within the biliary system.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FGE·November 7, 2008

    ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FGE·November 7, 2008

    Custom Angiographic Kit, K09-MS3084, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

    Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for fluid management convenience when catheterization is required.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code OEZ·January 29, 2009

    Infusion Pump

    FDA Recall
    Completed ·Baxter Healthcare Corporation·Product code FRN·January 6, 2021