MWS
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Stabilizer, Heart
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Medical specialty
- Cardiovascular
- Adverse events (MAUDE)
- 2021: 74 · 2022: 98 · 2023: 67 · 2024: 56 · 2025: 64 · 2026: 40
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 |
|---|---|---|
| MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES (K041338) | Medtronic Vascular | 2004-07-19 |
| PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (K992476) | Pilling Weck Surgical | 2000-09-13 |
| VACUUM ASSIST STABILIZER (K992833) | Cardio Thoracic Systems | 1999-11-10 |
| HEART-LIFT BALLOON POSITIONER (K982419) | Cardiothoracic Systems, Inc. | 1999-01-13 |
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Every clearance here is in the API, with alerts when new ones post.