FDA Registration
Active
🇺🇸 United States
MEDTRONIC XOMED, INC.
Reg #: 1219071
·
FEI: 1000159144
·
Expires 2026
Products
8
Proprietary Names
16
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- MEDTRONIC XOMED, INC.
- Registration Number
- 1219071
- FEI Number
- 1000159144
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 950 Flanders Rd
- City
- Mystic
- State
- CT
- ZIP
- 06355
- Country
- US
Regulatory Submissions
- 510(k) Number
- K923027
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2007-12-27 |
| Ear Wick | KCN | Class 1 | Ear, Nose, Throat | No | 1992-08-11 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 1995-04-18 |
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2007-12-27 |
| Splint, Intranasal Septal | LYA | Class 1 | Ear, Nose, Throat | No | 1993-10-26 |
| Anti Fog Solution And Accessories, Endoscopy | OCT | Class 2 | Gastroenterology, Urology | No | 2016-04-06 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 1992-08-11 |
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2007-12-27 |
Proprietary Names
MEROCEL SPONGES
MEROCEL EYE WICKS
MEROCEL AND KERACEL EYESPEARS
Merocel Pope Oto Wicks
Merocel Ear Packs, Post-Op
Merocel Schindler Ear Packing
Merocel Micro Spheres
Merocel Ambrus Ear Packing
Merocel Pope Ear Wicks
MEROCEL SPONGE
Neuray Surgical Patties and Strips
NASAL SPLINT
MEROCEL® HemoX
Endoscopic Laparoscopic Visual Improvement Sponge (ELVIS)
MEROCEL PACKINGS, DRESSINGS, ETC.
MEROCEL MICROSPHERES
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only