Contract manufacturerPIVOT - EDM (La Vista, NE)NebraskaEar, nose and throatGeneral and plastic surgeryPhysical medicineClass IClass II
PIVOT - EDM
Contract manufacturer ยท La Vista, NE
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3014903258 (openFDA record; or search FDA's registration database)
- FEI number
- 3014903258
- Registered for
- FDA registration year 2026
- Establishment types
- Specification developer; Contract manufacturer
- Owner or operator
- Pivot - EDM (FDA owner/operator no. 10061153)
- Registered address
- 12202 Cary Circle, La Vista, NE 68128
- Contract listings
- 4 device listings, 4 product codes, first listed Aug 30, 2019
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| ERA | Otoscope | Class I | Ear, nose and throat | Contract manufacturing | Aug 30, 2019 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class I | General and plastic surgery | Contract manufacturing | Dec 1, 2021 |
| KHX | Platform, Force-Measuring | Class I | Physical medicine | Contract manufacturing | Aug 30, 2019 |
| QPB | System, Suction, Lipoplasty For Removal | Class II | General and plastic surgery | Contract manufacturing | Jul 2, 2025 |