Contract manufacturerA&M BIOMEDICAL INC. (Laguna Hills, CA)CaliforniaCardiovascularNeurologyObstetrics and gynecologyOrthopedicGeneral and plastic surgeryClass II
A&M BIOMEDICAL INC.
Contract manufacturer ยท Laguna Hills, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2951215 (openFDA record; or search FDA's registration database)
- FEI number
- 1000221492
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- ambiomedical.com (FDA owner/operator no. 10042343)
- Registered address
- 23042 Alcalde Dr Ste A, Laguna Hills, CA 92653
- Contract listings
- 6 device listings, 6 product codes, first listed Dec 19, 2016
- 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 |
|---|---|---|---|---|---|
| DRC | Trocar | Class II | Cardiovascular | Contract manufacturing | Dec 19, 2016 |
| HAE | Rongeur, Manual | Class II | Neurology | Contract manufacturing | Jul 22, 2024 |
| HHW | Pessary, Vaginal | Class II | Obstetrics and gynecology | Contract manufacturing | Jan 7, 2025 |
| HRX | Arthroscope | Class II | Orthopedic | Contract manufacturing | Jul 25, 2017 |
| NEU | Marker, Radiographic, Implantable | Class II | General and plastic surgery | Contract manufacturing | Jan 7, 2025 |
| QUO | Adjunctive Heart Failure Status Indicator | Class II | Cardiovascular | Contract manufacturing | Jul 22, 2024 |