17 results
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28ms
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Sources: EU EUDAMED, US FDA
Kardium Inc.
Manufacturer
🇨🇦 Canada
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 Recall
Terminated
·Kardium 12851 Rowan Pl Richmond Canada British Columbia·Product code HXS·August 28, 2012
Kardium GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer