| Z-0108-2026 | Class II | Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED552 | September 5, 2025 |
| Z-2188-2025 | Class II | LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, | May 29, 2025 |
| Z-1121-2025 | Class II | MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 m | December 11, 2024 |
| Z-0990-2025 | Class II | Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX- | December 2, 2024 |
| Z-3157-2024 | Class II | ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanic | August 5, 2024 |
| Z-0868-2024 | Class II | TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 | December 21, 2023 |
| Z-0187-2024 | Class II | AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 | August 24, 2023 |
| Z-2238-2023 | Class II | FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, F | June 7, 2023 |
| Z-0170-2023 | Class II | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System. | September 21, 2022 |
| Z-0202-2022 | Class II | Aspiration Syringe Kit, REF: MVSK60 | October 20, 2021 |
| Z-1830-2021 | Class III | VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to b | April 21, 2021 |
| Z-1829-2021 | Class III | VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to b | April 21, 2021 |
| Z-1828-2021 | Class III | VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to b | April 21, 2021 |
| Z-1224-2020 | Class II | Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050 | November 24, 2019 |
| Z-1220-2020 | Class II | Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF number | November 24, 2019 |
| Z-1225-2020 | Class II | Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45- | November 24, 2019 |
| Z-1222-2020 | Class II | Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45- | November 24, 2019 |
| Z-1223-2020 | Class II | Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbe | November 24, 2019 |
| Z-1221-2020 | Class II | Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 4 | November 24, 2019 |
| Z-1399-2020 | Class II | MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 18 | November 22, 2019 |