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Boston Scientific FDA Approvals
0 new drug approvals and 20 device clearances on file. Matched by name to BSX.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Rezum System510(k)Sep 3, 2026Gastroenterology, Urology |
| AVVIGO+ Multi-Modality Guidance System510(k)Aug 21, 2026Cardiovascular |
| EluPro Antibiotic-Eluting BioEnvelope510(k)Aug 12, 2026General, Plastic Surgery |
| OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)510(k)Apr 8, 2026Cardiovascular |
| Orca Air/Water and Suction Valves510(k)Oct 9, 2025Gastroenterology, Urology |
| Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers510(k)Jul 3, 2025Gastroenterology, Urology |
| iSLEEVE Introducer Set510(k)Mar 20, 2025Cardiovascular |
| WallFlex Biliary PLUS RX Stent System510(k)Dec 6, 2024Gastroenterology, Urology |
| OBSIDIO Conformable Embolic510(k)Oct 3, 2024Cardiovascular |
| WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV510(k)Aug 30, 2024Gastroenterology, Urology |
| Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System510(k)Apr 29, 2024General, Plastic Surgery |
| ICEfx Cryoablation System (FPRCH8000-02)510(k)Mar 13, 2024General, Plastic Surgery |
| Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter510(k)Nov 28, 2023Gastroenterology, Urology |
| IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)510(k)Nov 22, 2023General, Plastic Surgery |
| Stingray LP Catheter510(k)May 25, 2023Cardiovascular |
| Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable510(k)Apr 25, 2023Cardiovascular |
| EKOS+ Endovascular Device510(k)Apr 20, 2022Cardiovascular |
| Emerge Monorail PTCA Dilatation Catheter510(k)Mar 24, 2022Cardiovascular |
| EkoSonic Endovascular Device510(k)Nov 19, 2021Cardiovascular |
| Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber510(k)Apr 28, 2021General, Plastic Surgery |