Contract manufacturerHARMAC MEDICAL PRODUCTS, INC. (Buffalo, NY)New YorkCardiovascularGastroenterology and urologyGeneral and plastic surgeryObstetrics and gynecologyOphthalmicGeneral hospitalClass IIClass IClass IIIHDE
HARMAC MEDICAL PRODUCTS, INC.
Contract manufacturer · Buffalo, NY
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1317547 (openFDA record; or search FDA's registration database)
- FEI number
- 1317547
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- HARMAC MEDICAL PRODUCTS, INC. (FDA owner/operator no. 1317547)
- Registered address
- 2201 BAILEY AVE., Buffalo, NY 14211
- Contract listings
- 19 device listings, 15 product codes, first listed Dec 20, 2007
- 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 |
|---|---|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | Class II | Cardiovascular | Contract manufacturing | Dec 20, 2007 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | Class II | Cardiovascular | Contract manufacturing | Dec 20, 2007 |
| DYG | Catheter, Flow Directed | Class II | Cardiovascular | Contract manufacturing | Dec 20, 2007 |
| FDP | Apparatus, Pneumoperitoneum, Automatic | Class II | Gastroenterology and urology | Contract manufacturing | Jan 25, 2013 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | Gastroenterology and urology | Contract manufacturing | Aug 3, 2020 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Jan 25, 2013 |
| GEA | Cannula, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Apr 23, 2018 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | Class II | General and plastic surgery | Contract manufacturing | Jul 27, 2017 |
| HIF | Insufflator, Laparoscopic | Class II | Obstetrics and gynecology | Contract manufacturing | Jan 25, 2013 |
| HQC | Unit, Phacofragmentation | Class II | Ophthalmic | Contract manufacturing | Mar 12, 2015 |
| JOL | Catheter And Tip, Suction | Class II | General hospital | Contract manufacturing | Mar 13, 2023 |
| LDF | Electrode, Pacemaker, Temporary | Class II | Cardiovascular | Contract manufacturing | Dec 20, 2007 |
| LNR | System, Photopheresis, Extracorporeal | Class III | Gastroenterology and urology | Contract manufacturing | Jan 25, 2013 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | Class II | General and plastic surgery | Contract manufacturing | May 28, 2015 |
| QNB | Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein | HDE | Gastroenterology and urology | Contract manufacturing | Mar 20, 2023 |