| Z-2221-2025 | Class II | Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and P | June 13, 2025 |
| Z-1270-2022 | Class II | Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 | May 16, 2022 |
| Z-1302-2022 | Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE | May 13, 2022 |
| Z-1301-2022 | Class III | Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 27 | May 13, 2022 |
| Z-0917-2022 | Class III | MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 30 | February 3, 2022 |
| Z-0901-2022 | Class III | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 | January 24, 2022 |
| Z-2043-2015 | Class II | Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part number | September 23, 2013 |
| Z-2045-2015 | Class II | ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. | September 23, 2013 |
| Z-2044-2015 | Class II | Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numb | September 23, 2013 |