139 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
×
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·November 20, 2024
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·November 20, 2024
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·November 20, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·November 20, 2024
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·November 20, 2024
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·November 20, 2024
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·November 20, 2024
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·April 3, 2024
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·April 3, 2024
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·September 10, 2025