# Boston Scientific Corporation (manufacturer, Saint Paul, MN): 24 new FDA device listings, incl. powered laser surgical instrument

**Score:** 95/100

| Field | Value |
|---|---|
| Establishment | Boston Scientific Corporation |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Saint Paul, MN, US |
| New listings | 24 |
| Devices | Powered Laser Surgical Instrument; Ureteroscope And Accessories, Flexible/Rigid; Catheter, Continuous Flush; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); System, Imaging, Pulsed Echo, Ultrasonic; Computer, Blood-Pressure; Computer, Diagnostic, Programmable; Transducer, Ultrasonic, Diagnostic; Hydrogel Spacer; Catheter, Ultrasound, Intravascular |
| Product codes | GEX, FGB, KRA, KNS, IYO, DSK, DQK, ITX, OVB, OBJ, PPN, FTM, LLZ, MTD, FGA |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Gastroenterology, Urology, Cardiovascular, Radiology |
| First new listing | 2026-05-12 |
| Latest new listing | 2026-10-16 |
| FDA registration number | 2124215 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.