JEA
10 FDA 510(k) clearances · Product code
39 daysmedian time to decision
229 days90th percentile
10clearances measured
FDA profile
- Official device name
- Table, Surgical With Orthopedic Accessories, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2021: 40 · 2022: 32 · 2023: 33 · 2024: 36 · 2025: 27 · 2026: 22
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 |
|---|---|---|
| STRYKER COMMAND2 OFFICE CONSOLE (K953071) | Stryker Instruments | 1995-08-08 |
| MEND APC (K924094) | Mend Technologies, Inc. | 1993-03-30 |
| JACKSON MULTIPURPOSE OPERATING TABLE (K910736) | Orthopedic Systems, Inc. | 1991-05-21 |
| ARTHROBOT(TM) WRIST HOLDER ACCESSORY (K911522) | Andronic Devices, Ltd. | 1991-04-29 |
| SKYTRON MODEL 1100 AND MODEL 142 (K900290) | Skytron, Div. the Kmw Group, Inc. | 1990-02-20 |
| DMI 250 SERIES POWER SURGERY TABLE (K894789) | M.D. Intl., Inc. | 1989-08-29 |
| OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) (K881060) | Orthopedic Systems, Inc. | 1988-03-25 |
| ARTHROTRACT UPPER LIMB TRACTION ACCESSORY (K874762) | Andronic Devices, Ltd. | 1987-12-10 |
| ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY (K873080) | Andronic Devices, Ltd. | 1987-11-25 |
| ARTHROBOT 100 UPPER LIMB POSITIONER (K873079) | Andronic Devices, Ltd. | 1987-11-25 |
Track JEA automatically
Every clearance here is in the API, with alerts when new ones post.