397 results
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41ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·June 17, 2026
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·May 13, 2026
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI, Model Number U228.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·May 6, 2026
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4. ESSENTIO DR SL MRI Pacemaker, Model Number L111; 5. ESSENTIO DR EL Pacemaker, Model Number L121; 6. ESSENTIO DR EL MRI Pacemaker, Model Number L131; 7. PROPONENT SR SL Pacemaker, Model Number L200; 8. PROPONENT DR SL Pacemaker, Model Number L201; 9. PROPONENT DR (VDD) SL Pacemaker, Model Number L209; 10. PROPONENT SR SL Pacemaker, Model Number L210; 11. PROPONENT DR SL MRI Pacemaker, Model Number L211; 12. PROPONENT DR EL Pacemaker, Model Number L221; 13. PROPONENT DR EL MRI Pacemaker, Model Number L231*; 14. ACCOLADE SR SL Pacemaker, Model Number L300; 15. ACCOLADE DR SL Pacemaker, Model Number L301; 16. ACCOLADE SR SL MRI Pacemaker, Model Number L310; 17. ACCOLADE DR SL MRI Pacemaker, Model Number L311; 18. ACCOLADE DR EL Pacemaker, Model Number L321; 19. ACCOLADE DR EL MRI Pacemaker, Model Number L331*; 20. ALTRUA 2 SR SL Pacemaker, Model Number S701; 21. ALTRUA 2 DR SL Pacemaker, Model Number S702; 22. ALTRUA 2 DR EL Pacemaker, Model Number S722.
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·May 6, 2026
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·March 18, 2026
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·February 11, 2026
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·January 21, 2026
TENACIO Pump with InhibiZone; UPN: 72404429;
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·October 22, 2025
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number U225 VISIONIST CRT-P EL
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL (Model L300)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number L221 PROPONENT DR EL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025