BEUDAMED
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    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.

    FDA Enforcement
    Class II ·Terminated·Biomet Spine, LLC·September 16, 2015

    Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler

    FDA Enforcement
    Class II ·Terminated·Surgical Tissue Network, Inc.·January 16, 2013

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Piston Syringe and Hypodermic Needle, 1 CC TB 28 G X 0.5, 100 per box, 30 boxes/case, 3,000/case

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444

    FDA Enforcement
    Class II ·Terminated·Bard Peripheral Vascular Inc·February 5, 2020

    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.

    FDA Enforcement
    Class II ·Terminated·Surgical Tissue Network, Inc.·January 16, 2013

    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.

    FDA Enforcement
    Class II ·Terminated·Surgical Tissue Network, Inc.·January 16, 2013

    SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

    FDA Enforcement
    Class II ·Terminated·SCC Soft Computer·May 21, 2014

    SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.

    FDA Enforcement
    Class II ·Terminated·SCC Soft Computer·August 15, 2012

    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0

    FDA Enforcement
    Class II ·Terminated·SCC Soft Computer·February 18, 2015

    SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

    FDA Enforcement
    Class II ·Terminated·SCC Soft Computer·February 11, 2015

    Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    Piston Syringe and Hypodermic Needle, 1 CC TB 25 G X 5/8, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.

    FDA Enforcement
    Class II ·Terminated·International Medsurg Connection, Inc.·August 16, 2017

    The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedure. The system may be used for other imaging applications at the physician's discretionOEC 9900 Elite. MDL Numbers: D148942, D155043

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·January 18, 2017

    OEC UroView 2800, fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 31, 2016

    GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·January 21, 2015