10 results
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29ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.
FDA Enforcement
Class II
·Ongoing·Volcano Corp·August 6, 2025
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
FDA Enforcement
Class II
·Terminated·Volcano Corp·June 22, 2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 2797
FDA Enforcement
Class III
·Ongoing·Volcano Corp·July 6, 2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 2797
FDA Enforcement
Class III
·Ongoing·Volcano Corp·July 6, 2022
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Enforcement
Class II
·Terminated·Volcano Corp·July 15, 2015
ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Enforcement
Class II
·Terminated·Volcano Corp·July 15, 2015
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
FDA Enforcement
Class II
·Terminated·Volcano Corp·July 15, 2015
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
FDA Enforcement
Class III
·Ongoing·Volcano Corp·April 20, 2022
MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems
FDA Enforcement
Class III
·Ongoing·Volcano Corp·April 20, 2022
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Volcano Corporation·May 23, 2018