FDA Registration
Active
🇺🇸 United States
NIKOMED U.S.A., INC.
Reg #: 2245574
·
FEI: 2245574
·
Expires 2026
Products
15
Proprietary Names
22
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- NIKOMED U.S.A., INC.
- Registration Number
- 2245574
- FEI Number
- 2245574
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2800 Turnpike Dr
- City
- Hatboro
- State
- PA
- ZIP
- 19040
- Country
- US
Regulatory Submissions
- 510(k) Number
- K993306
Owner / Operator
- Firm Name
- NIKOMED U.S.A., INC.
- Operator Number
- 9023845
- Address
- 2800 Turnpike Drive
- City
- Hatboro
- State
- PA
- Postal Code
- 19040
- Country
- US
- Correspondent
- STEPHEN - EPSTEIN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2018-03-14 |
| Apparatus, Electrosurgical | HAM | Class 2 | General, Plastic Surgery | No | 2026-04-30 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-04-30 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-12-09 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-03-27 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2018-06-26 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | Class 2 | Cardiovascular | No | 2019-04-04 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2019-03-19 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2014-12-31 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-06-11 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2019-03-18 |
| Device, Vein Location, Liquid Crystal | KZA | Class 1 | General Hospital | No | 2019-06-18 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-02-24 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-02-24 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-08-26 |
Proprietary Names
NIKOClips
NIKOTABS
NIKOPrep
NIKOTRACE
NIKOSURG
NIKO-Surg
TRACE1
NIKO THERMAL REFLECTORS
Paco-flow orthopedic suction tip
Gallant Disposable Prep Razor
ME Medical Surgical Clipper
MESI BP Cuffs
Nikomed ECG Cable
Coreshieldz
Disposable Non-Surgical Gown
CPR Mask
Vivolight
MESI ABPI MD
MESI mTABLET ABI
Moldex
3M
Safety Goggles
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility