HDD
7 FDA 510(k) clearances · Product code
116 daysmedian time to decision
230 days90th percentile
7clearances measured
FDA profile
- Official device name
- Table, Obstetrical, Ac-Powered (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4900
- Medical specialty
- Obstetrics/Gynecology
- Adverse events (MAUDE)
- 2019: 14 · 2020: 17 · 2021: 19 · 2022: 14 · 2023: 19 · 2024: 19
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 |
|---|---|---|
| ADEL 5000 (K950889) | Stryker Corp. | 1995-10-16 |
| THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES (K914309) | Hill-Rom, Inc. | 1992-04-20 |
| ORCEPAD (K875123) | Alton Dean Medical, Inc. | 1988-06-21 |
| ADEL MODEL 2100 BIRTHING BED (K874610) | Adel Medical , Ltd. | 1988-01-21 |
| ADEL MEDICAL BIRTHING BED, #LD-500 (K810886) | Adel Medical , Ltd. | 1981-04-23 |
| TILT 10, CATALOG #S-2600 (K771942) | Affiliated Hospital Products, Inc. | 1977-10-27 |
| CART, PROCEDURES (K770438) | I E Industries | 1977-07-01 |
Track HDD automatically
Every clearance here is in the API, with alerts when new ones post.