BEUDAMED
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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·June 8, 2016

    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

    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

    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·June 5, 2019

    RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications

    FDA Enforcement
    Class II ·Terminated·RTI Surgical, Inc.·March 22, 2017

    OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Osteomed, LLC·June 10, 2020

    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

    OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020

    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