Boston Scientific Corporation
Dispositifs autorisés FDA 510(k) et PMA — 167 produits
Publicité
Nombre total de dispositifs167
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K262151 | SpaceOAR Flex™ System | OVB | 2026-09-11 | Voir |
| 510(k) | K261153 | LithoVue Elite Digital Flexible Ureteroscope System | FGB | 2026-08-26 | Voir |
| 510(k) | K261915 | Navigator™ Flex Ureteral Access Sheath Set | FED | 2026-08-04 | Voir |
| 510(k) | K262462 | TheraSphere 360™ Y-90 Management Platform | LLZ | 2026-07-24 | Voir |
| 510(k) | K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | DRA | 2026-07-24 | Voir |
| 510(k) | K261488 | OBSIDIO Conformable Embolic | KRD | 2026-07-24 | Voir |
| 510(k) | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | ESW | 2026-07-10 | Voir |
| 510(k) | K260428 | RIVOS™ EUS Access Device (M00553900) | ODG | 2026-06-17 | Voir |
| 510(k) | K260100 | MOSES Raydar™ | GEX | 2026-05-18 | Voir |
| 510(k) | K260771 | TruSelect™ 2.6 Microcatheter | KRA | 2026-05-15 | Voir |
| 510(k) | K251273 | Asurys Fluid Management System | HIG | 2026-03-27 | Voir |
| 510(k) | K260479 | TheraSphere 360™ Y-90 Management Platform | LLZ | 2026-03-13 | Voir |
| 510(k) | K260119 | SpaceOAR Vue System (SV-2101) | OVB | 2026-02-10 | Voir |
| 510(k) | K252529 | Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120) | GEX | 2025-10-30 | Voir |
| 510(k) | K253376 | OBSIDIO™ Conformable Embolic (M0013972101010) | KRD | 2025-10-30 | Voir |
| 510(k) | K252547 | TheraSphere 360™ Y-90 Management Platform | LLZ | 2025-10-28 | Voir |
| 510(k) | K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | BWH | 2025-09-26 | Voir |
| 510(k) | K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) | FGB | 2025-09-24 | Voir |
| 510(k) | K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | MXD | 2025-09-12 | Voir |
| 510(k) | K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers | GEX | 2025-07-09 | Voir |
Aucun dispositif correspondant.