Device, Cystometric, Hydraulic (FEN) contract manufacturers
13 US facilities list FDA product code FEN as a contract manufacturer (4) or contract sterilizer (9).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Device, Cystometric, Hydraulic
- Product code
- FEN (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 876.1620
- Classification panel
- Gastroenterology and urology
Where they are
Georgia 2 · New York 2 · Texas 2 · Utah 2 · California 1 · Illinois 1 · Massachusetts 1 · New Jersey 1 · Ohio 1
All 13 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| C.R. BARD, INC. | 1018233 | Contract sterilizer | Gastroenterology and urology; Cardiovascular; General and plastic surgery +4 more | Covington, GA | Not verified | Oct 21, 2026 |
| C.R. BARD, INC. | 1313046 | Contract manufacturer | Cardiovascular; Gastroenterology and urology; General hospital +1 more | Queensbury, NY | Not verified | Oct 21, 2026 |
| C.R. BARD, INC. | 3006082230 | Contract sterilizer | Gastroenterology and urology; Cardiovascular; General and plastic surgery +4 more | Madison, GA | Not verified | Oct 21, 2026 |
| CLINICAL INNOVATIONS, LLC | 1722684 | Contract manufacturer | Gastroenterology and urology | Murray, UT | Not verified | Oct 21, 2026 |
| COGENTIX MEDICAL, INC. | 1223490 | Contract manufacturer | Gastroenterology and urology | Westborough, MA | Not verified | Oct 21, 2026 |
| ICU Medical, Inc. | 1526863 | Contract manufacturer | Anesthesiology; Gastroenterology and urology; Cardiovascular +2 more | Dublin, OH | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1720929 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +11 more | Sandy, UT | Not verified | Oct 21, 2026 |
| Isomedix Operations Inc. | 2246552 | Contract sterilizer | General and plastic surgery; Orthopedic; Gastroenterology and urology +12 more | S Plainfield, NJ | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc | 2032098 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +12 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 1450662 | Contract sterilizer | Orthopedic; General and plastic surgery; Cardiovascular +11 more | Libertyville, IL | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1319639 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +14 more | Queensbury, NY | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 3004111573 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +15 more | Grand Prairie, TX | Not verified | Oct 21, 2026 |
| Steritec Services, LLC | 1647149 | Contract sterilizer | Gastroenterology and urology; Orthopedic; Cardiovascular +4 more | Athens, TX | Not verified | Oct 21, 2026 |
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