Contract manufacturerBIOSCULPTOR CORPORATION (Hialeah, FL)FloridaGeneral and plastic surgeryOrthopedicPhysical medicineClass I
BIOSCULPTOR CORPORATION
Contract manufacturer ยท Hialeah, FL
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1000560772 (openFDA record; or search FDA's registration database)
- FEI number
- 1000560772
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer
- Owner or operator
- BioSculptor Corporation (FDA owner/operator no. 10028416)
- Registered address
- 2480 W 82nd St Unit 1, Hialeah, FL 33016
- Contract listings
- 6 device listings, 6 product codes, first listed Jan 5, 2015
- 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 |
|---|---|---|---|---|---|
| FYH | Splint, Extremity, Noninflatable, External, Sterile | Class I | General and plastic surgery | Contract manufacturing | Jan 5, 2015 |
| HSP | Splint, Traction | Class I | Orthopedic | Contract manufacturing | Jan 5, 2015 |
| ILH | Splint, Hand, And Components | Class I | Physical medicine | Contract manufacturing | Jan 5, 2015 |
| IQI | Orthosis, Limb Brace | Class I | Physical medicine | Contract manufacturing | Jan 5, 2015 |
| ITW | Joint, Ankle, External Brace | Class I | Physical medicine | Contract manufacturing | Jan 5, 2015 |
| OHI | Orthosis, Foot Drop | Class I | Physical medicine | Contract manufacturing | Jan 5, 2015 |