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    Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp. d.b.a. Integra Pain Management·November 4, 2015

    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 25, 2015

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·May 21, 2025

    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

    FDA Enforcement
    Class II ·Ongoing·ICU Medical, Inc.·December 31, 2025

    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094

    FDA Enforcement
    Class II ·Terminated·GETINGE US SALES LLC·May 30, 2018

    MIM software; System, Image Processing, Radiological

    FDA Enforcement
    Class II ·Ongoing·MIM Software Inc·March 12, 2025

    Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage Catheter-ULT12.0-38-45-P-6S-CLM-RH-ntended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique ORDER NUMBER: GPN:G09767

    FDA Enforcement
    Class II ·Ongoing·Cook Incorporated·July 3, 2024

    Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare Inc.·July 11, 2012

    Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

    FDA Enforcement
    Class II ·Terminated·Maquet Medical Systems USA·June 18, 2014