JDZ
13 FDA 510(k) clearances · Product code
62 daysmedian time to decision
241 days90th percentile
13clearances measured
FDA profile
- Official device name
- Mixer, Cement, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4210
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 2021: 58 · 2022: 46 · 2023: 65 · 2024: 28 · 2025: 20 · 2026: 228
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 |
|---|---|---|
| EXACTECH ALL POLY ACETABULAR CUP (K934253) | Exactech, Inc. | 1994-04-29 |
| PRISM BONE CEMENT MIXING SYSTEM (K925025) | Depuy, Inc. | 1994-01-05 |
| STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST (K912190) | Stryker Corp. | 1991-08-29 |
| REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS (K892937) | Dentsply Intl. | 1989-06-22 |
| ZIMMER VACUUM MIXING SYSTEM (K861086) | Zimmer, Inc. | 1986-04-14 |
| MIX EVAC II (K854077) | Stryker Corp. | 1986-01-31 |
| SIMPLEX ENHANCEMENT MIXER (K853310) | Howmedica Corp. | 1985-09-11 |
| CEMENTRIFUGE (K851205) | Biodynamic Technologies, Inc. | 1985-07-16 |
| ZIMMER BONE CEMENT CENTRIFUGATION SYS (K843219) | Zimmer, Inc. | 1984-11-29 |
| HOWMEDICA MIX-KIT II (K792186) | Howmedica Corp. | 1979-12-05 |
| MIXING BOWL & SPATULA, DISPOSABLE (K780857) | Howmedica Corp. | 1978-06-13 |
| ORTHOMIX (K760636) | Diemolding Corp. | 1976-10-05 |
| MIX EVAC BONE CEMENT (K760617) | Stryker Corp. | 1976-10-05 |
Track JDZ automatically
Every clearance here is in the API, with alerts when new ones post.