Contract manufacturerMCLEAN MEDICAL & SCIENTIFIC (Saint Paul, MN)MinnesotaCardiovascularDentalGeneral and plastic surgeryGastroenterology and urologyNeurologyObstetrics and gynecologyOrthopedicEar, nose and throatClass IClass II
MCLEAN MEDICAL & SCIENTIFIC
Contract manufacturer ยท Saint Paul, MN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2183570 (openFDA record; or search FDA's registration database)
- FEI number
- 2183570
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- MCLEAN MEDICAL & SCIENTIFIC (FDA owner/operator no. 2183570)
- Registered address
- 328 State Street, Saint Paul, MN 55107
- Contract listings
- 34 device listings, 35 product codes, first listed Feb 7, 1985
- 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 |
|---|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Class I | Cardiovascular | Contract manufacturing | Dec 20, 2012 |
| EME | Punch, Biopsy, Surgical | Class I | Dental | Contract manufacturing | Dec 20, 2012 |
| EPY | Speculum, Ent | Class I | General and plastic surgery | Contract manufacturing | Jan 11, 2013 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Class I | Gastroenterology and urology | Contract manufacturing | Dec 20, 2012 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract manufacturing | Dec 20, 2012 |
| FFO | Retractor, Self-Retaining | Class I | Gastroenterology and urology | Contract manufacturing | Dec 20, 2012 |
| FHN | Ligator, Hemorrhoidal | Class II | Gastroenterology and urology | Contract manufacturing | Nov 7, 2013 |
| FHQ | Holder, Needle, Gastroenterologic | Class I | Gastroenterology and urology | Contract manufacturing | Feb 7, 1985 |
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Feb 7, 1985 |
| GAC | Rasp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Feb 7, 1985 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Jan 11, 2013 |
| GCT | Light Source, Endoscope, Xenon Arc | Class II | Gastroenterology and urology | Contract manufacturing | Dec 20, 2012 |
| GDG | Hook, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jan 11, 2013 |
| GDI | Dissector, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Feb 7, 1985 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jan 11, 2013 |
| GDZ | Handle, Scalpel | Class I | General and plastic surgery | Contract manufacturing | Feb 13, 2013 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Dec 20, 2012 |
| GEN | Forceps, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Dec 20, 2012 |
| GFF | Bur, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Feb 13, 2013 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Jan 11, 2013 |
| GZX | Instrument, Microsurgical | Class I | Neurology | Contract manufacturing | Feb 7, 1985 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jan 11, 2021 |
| HFB | Forceps, Biopsy, Gynecological | Class I | Obstetrics and gynecology | Contract manufacturing | Dec 20, 2012 |
| HTC | Pliers, Surgical | Class I | General and plastic surgery | Contract manufacturing | Jan 11, 2013 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Feb 13, 2013 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Feb 13, 2013 |
| HTX | Rongeur | Class I | Orthopedic | Contract manufacturing | Dec 20, 2012 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Jan 11, 2013 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Jan 11, 2013 |
| KAE | Forceps, Ent | Class I | Ear, nose and throat | Contract manufacturing | Dec 20, 2012 |
| KDG | Chisel (Osteotome) | Class I | General and plastic surgery | Contract manufacturing | Dec 20, 2012 |
| LRC | Instrument, Ent Manual Surgical | Class I | Ear, nose and throat | Contract manufacturing | Feb 4, 2021 |
| LRW | Scissors, General, Surgical | Class I | General and plastic surgery | Contract manufacturing | Dec 20, 2012 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Dec 19, 2014 |
| MDM | Instrument, Manual, Surgical, General Use | Class I | General and plastic surgery | Contract manufacturing | Jan 11, 2013 |