KIH
11 FDA 510(k) clearances · Product code
34 daysmedian time to decision
65 days90th percentile
11clearances measured
FDA profile
- Official device name
- Dispenser, Cement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4200
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 30 · 2022: 26 · 2023: 30 · 2024: 19 · 2025: 93 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SMARTMIX PRE-FILLED MIXING SYSTEM (K042591) | DePuy Orthopaedics, Inc. | 2004-10-22 |
| P.F.C. CEMENT PRESSURIZING SYSTEM (K943906) | Johnson & Johnson Professionals, Inc. | 1994-12-21 |
| CMW CEMENT PRESSURISATION SYSTEM (K897134) | Dentsply Intl. | 1990-03-02 |
| ORTHOPEADIC CEMENT DELIVERY SYSTEM (K851881) | Dentsply Intl. | 1985-06-13 |
| PRESSURIZING/SCAVENGING ACRYLIC CEMENT (K840046) | Precision Medical Devices, Inc. | 1984-02-09 |
| BRIGHAM TIBIAL CEMENT PRESSURIZER (K833675) | Howmedica Corp. | 1983-12-12 |
| HOWMEDICA FEMORAL PRESSURING SEAL (K811317) | Howmedica Corp. | 1981-05-29 |
| OH-HARRIS (K801388) | Johnson & Johnson Professionals, Inc. | 1980-07-28 |
| GUN, EXETER CEMENT (K790275) | Howmedica Corp. | 1979-02-21 |
| GUN, CEMENT (K781955) | Depuy, Inc. | 1978-12-04 |
| BONE CEMENT APPLICATOR (K780266) | Zimmer, Inc. | 1978-02-28 |
Track KIH automatically
Every clearance here is in the API, with alerts when new ones post.