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    KARDIUM Inc.

    FDA registration
    KARDIUM Inc.·7 products·🇨🇦 Canada

    Globe® Workstation

    FDA UDI
    Kardium Inc·07540162100307·

    Globe Positioning System (GPS™) Electrodes

    FDA UDI
    Kardium Inc·07540162100253·

    Globe Positioning System (GPS™) Cable

    FDA UDI
    Kardium Inc·07540162100239·

    Globe® Platform

    FDA UDI
    Kardium Inc·07540162100338·

    Globe® Catheter Cable

    FDA UDI
    Kardium Inc·07540162100277·

    Globe® Catheter Cable Support

    FDA UDI
    Kardium Inc·07540162100352·

    Globe® Catheter

    FDA UDI
    Kardium Inc·07540162100154·

    Globe® Controller

    FDA UDI
    Kardium Inc·07540162100291·

    Globe® PF Generator

    FDA UDI
    Kardium Inc·07540162100321·

    Globe® Introducer

    FDA UDI
    Kardium Inc·07540162100185·

    TORQ STERNAL CLOSURE DEVICE

    FDA Adverse Event
    Malfunction ·KARDIUM INC.·Product code LXH·September 10, 2012

    TORQ STERNAL CLOSURE DEVICE

    FDA Adverse Event
    Malfunction ·KARDIUM INC.·Product code LXH·April 1, 2010

    TORQ Sternal Closure Device, SINGLE-USE Intended use: The device is a sterile, single-use only surgical instrument used to tension and twist USP size 5, 6, and 7 (metric size 7.0, 8.0, and 9.0) stainless steel surgical sutures for sternal closure. The device should not be used on patients with poor sternal bone quality.

    FDA Recall
    Terminated ·KARDIUM INC. 100·Product code HXS·March 31, 2010

    TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile.

    FDA Enforcement
    Class II ·Terminated·Kardium·October 17, 2012

    TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile.

    FDA Recall
    Terminated ·Kardium 12851 Rowan Pl Richmond Canada British Columbia·Product code HXS·August 28, 2012

    ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GCJ·April 17, 2006

    MOSES PULSE

    FDA Adverse Event
    Injury ·LUMENIS LTD·Product code GEX·May 28, 2026

    XI 30 ENDOWRIST STAPLER

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL INC·Product code NAY·December 20, 2018

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·February 1, 2024