FDA Registration
Active
🇺🇸 United States
CADENCE DEVICE, INC.
Reg #: 3010659131
·
FEI: 3010659131
·
Expires 2026
Products
13
Proprietary Names
1
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- CADENCE DEVICE, INC.
- Registration Number
- 3010659131
- FEI Number
- 3010659131
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 250 W KENSINGER DR STE 400
- City
- Cranberry Township
- State
- PA
- ZIP
- 16066
- Country
- US
Owner / Operator
- Firm Name
- Cadence Device, Inc.
- Operator Number
- 10045803
- Address
- 250 West Kensinger Dr. Suite 400
- City
- Cranberry Township
- State
- PA
- Postal Code
- 16066
- Country
- US
- Correspondent
- Robert Hegedus
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2023-06-13 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2015-12-07 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2017-12-15 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2014-12-03 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2016-12-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-08-07 |
| Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | MXC | Class 2 | Cardiovascular | No | 2017-12-12 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2020-08-06 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2018-10-15 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2020-12-31 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2025-05-21 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-05-13 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2021-07-23 |
Proprietary Names
IVX Station Stock Solution Transfer Set
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)