Automated External Defibrillators (Non-Wearable) (MKJ) contract manufacturers
9 US facilities list FDA product code MKJ as a contract manufacturer (7) or contract sterilizer (2).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Automated External Defibrillators (Non-Wearable)
- Product code
- MKJ (FDA product classification database)
- Device class
- Class III
- Regulation
- 21 CFR 870.5310
- Classification panel
- Cardiovascular
Where they are
California 2 · Iowa 1 · Illinois 1 · Massachusetts 1 · New York 1 · Rhode Island 1 · Utah 1 · Wisconsin 1
All 9 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ANSEN CORPORATION | 3003867964 | Contract manufacturer | Cardiovascular | Ogd, NY | Not verified | Oct 21, 2026 |
| Cardinal Health | 1219103 | Contract manufacturer | Cardiovascular; General hospital; General and plastic surgery | Chicopee, MA | 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 |
| ITECH | 3002714378 | Contract manufacturer | Cardiovascular; General and plastic surgery | San Diego, CA | Not verified | Oct 21, 2026 |
| KATECHO LLC | 1930027 | Contract manufacturer | Cardiovascular; Neurology; Physical medicine +7 more | Des Moines, IA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1423662 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Gurnee, IL | Not verified | Oct 21, 2026 |
| TECAN CDMO SOLUTIONS MH, CORP. | 3003537036 | Contract manufacturer | Gastroenterology and urology; Clinical chemistry; General and plastic surgery +4 more | Morgan Hill, CA | Not verified | Oct 21, 2026 |
| ZOLL Medical Corporation | 1218058 | Contract manufacturer | Cardiovascular; Anesthesiology | Pawtucket, RI | Not verified | Oct 21, 2026 |
| ZOLL Medical Corporation | 2112020 | Contract manufacturer | Cardiovascular; Anesthesiology | Deerfield, WI | Not verified | Oct 21, 2026 |
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