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    Enovare

    FDA UDI
    OREON TECHNOLOGIES INC.·08638750003013·diagnostic ultrasound system

    ON-X MITRAL PROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·November 12, 2014

    2.5MM DRILL BIT CALIBRATED 200MM

    FDA Adverse Event
    Malfunction ·OSTEOCENTRIC TECHNOLOGIES, INC.·Product code HTW·December 6, 2023

    4.0 X 38MM SCREW SUPER FASTENER, ST

    FDA Adverse Event
    Malfunction ·OSTEOCENTRIC TECHNOLOGIES, INC.·Product code HWC·December 8, 2023

    OSTEOCENTRIC 4.0 X 48MM LOCKING BONE SCREW FASTENER ST

    FDA Adverse Event
    Malfunction ·OSTEOCENTRIC TECHNOLOGIES, INC.·Product code HWC·December 8, 2023

    HISTOFREEZER FREEZING DEVICE

    FDA Adverse Event
    Malfunction ·STC TECHNOLOGIES, INC.·Product code KSE·March 10, 1999

    Morton IUI Catheter, Sterile, Single Use Only, Order #: ftr510, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter for Trial Transfer, 20 cm, Order #: ftr320, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 20 cm, Sterile, Single Use Only, Order #: ftr 220, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 23 cm, Order #: ftr123, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter with URM Tip, Embryo Transfer Catheter, 20 cm, Order #: ftr120, Manufactured by: Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Tucker Embryo Catheter, Stylet, For use with Embryo Transfer Catheter, 23 CM, Sterile, Single Use Only, Order #: ft r 223, Manufactured by Fertility Technology Resources, Inc., Marietta, GA 30062

    FDA Recall
    Terminated ·Fertility Technology Resources, Inc.·Product code MQF·September 13, 2007

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 12, 2013

    Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 4 -Towel; 1 -19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syringe L/L; 1 - Ruler; 2 4" x 4" Sponges in stacks of 5; 1 - " x 3" Bandage; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 -1% Lidocaine (5mL); 1 - CSR Wrap***Catalog Number: CG0305***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 22ga x 1-1/2" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 2 - 1% Lidocaine (5mL); 1 - " x 3" Bandage; 1 - Towel; 1 - CSR Wrap; 1 - Lidocaine Insert; 1 - Ruler with Protractor; 1 - 4" x 4" Sponges in stacks of 5***Catalog Number: CG00552***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syringe L/L; 4 - Towel; 1 - Ruler; 1 - 4" x 4" Sponges in stacks of 5; 1 - " x 3" Bandage; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 2% Lidocaine (10mL) ; 1 - CSR Wrap***Catalog Number: CG0287***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc Syringe L/L; 1- 25ga x 5/8" Needle; 1 - 21ga x 1-1/2" Needle;1- 19ga x 1-1/2" Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - " x 3" Bandage; 2 - Towel; 1 - Fenestrated Drape; 2 - 15mL Specimen Tube; 2 - Specimen Label; 1 - Ruler; 1 - CSR Wrap***Catalog Number: GUTS1000***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom General Biopsy Tray for OMA North of Oklahoma City*** 1 - 60cc Syringe; 2 - 10cc Syringe L/L; 1 -18ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 50cm Extension Tube; 1 - 10% Povidone Iodine Swab Sticks (3Pkg); 1 - 1% Lidocaine (5mL); 1 - 3" x 3" Sponges is stacks of 5 (4-Ply); 1 - Fenestrated Drape; 1 - Towel; 1 - CSR Wrap***Catalog Number: CG0072***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

    Angiotech***Custom General Biopsy Tray for St. Johns Mercy Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 -21ga x 1-1/2 Needle; 1 - 25ga x 5/8 Needle; 1 - 19ga x 1-1/2 Filter Needle; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 - 1% Lidocaine (5mL); 1 - Specimen Label; 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 3 x 3 Sponges in stacks of 5 (4-Ply); 1 - x 3 Bandage; 1 - Towel; 1 - CSR Wrap***Catalog Number: CG0236***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010