7 results
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6ms
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Sources: EU EUDAMED, US FDA
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016
AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.
FDA Enforcement
Class II
·Terminated·Angiodynamics Worldwide Headquarters·August 15, 2012
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
FDA Enforcement
Class II
·Terminated·Cook Inc.·August 31, 2016