BEUDAMED
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    SELF-SEALING WATER TRAP/ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    CXI Support Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADVISA DR MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 10, 2014

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2010

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 6, 2012

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 18, 2019

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 2, 2020

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 18, 2021

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 21, 2021

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·June 21, 2019

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·January 25, 2024

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·January 29, 2019

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 12, 2020

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·March 12, 2020

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·December 8, 2022

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·March 31, 2022

    CXI SUPPORT CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·October 10, 2019

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 130-40-53 d. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 4 CUPS, REF 130-40-54 e. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 5 CUPS, REF 130-40-55 f. NOVATION GXL LINER LIPPED 32MM ID, GROUP 1 CUPS, REF 132-32-51 g. NOVATION GXL LINER LIPPED 36MM ID GROUP 2, REF 132-36-52 h. NOVATION GXL LINER LIPPED 40MM ID, GROUP 3 CUPS, REF 132-40-53 i. NOVATION GXL LINER LIPPED 40MM ID, GROUP 4 CUPS, REF 132-40-54 j. NOVATION GXL LINER LIPPED 40MM ID, GROUP 5 CUPS, REF 132-40-55 k. NOVATION GXL LINER +5 LAT 40MM GROUP 3 CUPS, REF 136-40-53 l. NOVATION GXL LINER +5 LAT 40MM ID GROUP 4 CUPS, REF 136-40-54 m. NOVATION GXL LINER +5 LAT 40MM ID GROUP 5 CUPS, REF 136-40-55 n. NOVATION GXL LINER 10 DEG FACE 40MM ID, GRP 3 CUP, REF 138-40-53 o. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 4 CUP, REF 138-40-54 p. NOVATION GXL LINER 10 DEG FACE, 40MM ID, GRP 5 CUP, REF 138-40-55

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012