Contract manufacturerAble Medical Devices (Marquette, MI)MichiganGeneral and plastic surgeryOrthopedicClass I
Able Medical Devices
Contract manufacturer ยท Marquette, MI
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3038776593 (openFDA record; or search FDA's registration database)
- FEI number
- 3038776593
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- Able Medical Devices (FDA owner/operator no. 10058122)
- Registered address
- 2812 Beecher Street, Marquette, MI 49855
- Contract listings
- 9 device listings, 9 product codes, first listed Mar 18, 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 |
|---|---|---|---|---|---|
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Dec 8, 2022 |
| HTC | Pliers, Surgical | Class I | General and plastic surgery | Contract manufacturing | Dec 28, 2023 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Nov 20, 2019 |
| HXC | Wrench | Class I | Orthopedic | Contract manufacturing | Dec 18, 2025 |
| HXG | Tamp | Class I | Orthopedic | Contract manufacturing | Mar 18, 2019 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Mar 18, 2019 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Mar 18, 2019 |
| LXI | Guide, Drill, Ligament | Class I | General and plastic surgery | Contract manufacturing | Dec 18, 2025 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Dec 18, 2025 |