FDA Registration
Active
🇺🇸 United States
BOSTON SCIENTIFIC CORPORATION
Reg #: 3032507796
·
FEI: 3032507796
·
Expires 2026
Products
13
Proprietary Names
0
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- BOSTON SCIENTIFIC CORPORATION
- Registration Number
- 3032507796
- FEI Number
- 3032507796
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 11480 Lakefield Drive
- City
- Johns Creek
- State
- GA
- ZIP
- 30097
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153588
Owner / Operator
- Firm Name
- Boston Scientific Corporation
- Operator Number
- 9912058
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
- Correspondent
- Adrienne Bishop
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2016-12-22 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | Class 2 | Gastroenterology, Urology | No | 2016-12-22 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2018-09-21 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2008-01-15 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2025-12-31 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2022-04-13 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2016-12-22 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2016-12-23 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2016-12-23 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2018-12-07 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2001-10-11 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2016-12-22 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2023-11-15 |
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device