32 results
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13ms
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Sources: EU EUDAMED, US FDA
OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
General Surgery Pack, part number PSS1380(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
HSG Pack, part number PSS3287
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Morris Hysto Pack, part number PSS3198(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Basic Kit, part number CMP1109(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Plastic Pack, part number PSS2462 Plastic Pack, part number PSS3319 Plastic Pack, part number PSS3319(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Laparotomy Pack, part number 006268-9 Laparotomy Pack, part number AMS4418(A Laparotomy Pack, part number PSS2190(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Set Up Pack, part number PSS3574(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film sterilizable outer pouch.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017
OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
FDA Enforcement
Class II
·Terminated·Oscor, Inc.·December 28, 2016
Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016