Dilator, Urethral (KOE) contract manufacturers
14 US facilities list FDA product code KOE as a contract manufacturer (3) or contract sterilizer (11).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Dilator, Urethral
- Product code
- KOE (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 876.5520
- Classification panel
- Gastroenterology and urology
Where they are
Georgia 3 · Indiana 2 · Tennessee 2 · Texas 2 · Minnesota 1 · Missouri 1 · New York 1 · Oklahoma 1 · South Carolina 1
All 14 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| BIOMERICS FMI | 1646831 | Contract manufacturer | Gastroenterology and urology; Cardiovascular; Ear, nose and throat | Athens, TX | Not verified | Oct 21, 2026 |
| 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 |
| COOK INCORPORATED | 1000393132 | Contract sterilizer | Gastroenterology and urology; General and plastic surgery; Cardiovascular +8 more | Ellettsville, IN | Not verified | Oct 21, 2026 |
| DEROYAL INDUSTRIES, INC. | 1055236 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| DeRoyal Industries, Inc. | 1054241 | Contract sterilizer | General and plastic surgery; General hospital; Gastroenterology and urology +14 more | New Tazewell, TN | Not verified | Oct 21, 2026 |
| GOODWILL COMMERCIAL SERVICES | 3043337628 | Contract manufacturer | Gastroenterology and urology; Cardiovascular; Anesthesiology | Indianapolis, IN | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC. | 1047843 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; Orthopedic +13 more | Spartanburg, SC | Not verified | Oct 21, 2026 |
| Isomedix Operations, Inc. | 2183744 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +13 more | Minneapolis, MN | Not verified | Oct 21, 2026 |
| MIDWEST STERILIZATION CORP. | 1928237 | Contract sterilizer | General and plastic surgery; Cardiovascular; General hospital +14 more | Jackson, MO | Not verified | Oct 21, 2026 |
| MedXL | 1644312 | Contract sterilizer | General and plastic surgery; General hospital; Cardiovascular +9 more | Ardmore, OK | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 1018470 | Contract sterilizer | General and plastic surgery; Orthopedic; General hospital +12 more | Atlanta, GA | 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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