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Sign in to claim this brandStryker Medical
United States·US-MF-000000542
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3800, E. Centre Ave., Portage, United States
- Website
- www.stryker.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- John Mack
- EUDAMED SRN
- US-MF-000000542
- FDA FEI Number
- 1831750
- DUNS Number
- —
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Support Surface Accessories - Extender Pads | 70024520 | EUDAMED | Class I | Active |
| Mv3 | 5900-000-001 | EUDAMEDFDA UDI | Class I | Active |
| Stryker Agility Intensive Care Bed | K946149 | FDA 510(k) | Class II | Active |
| Altrix Precision Temperature Management System | K180834 | FDA 510(k) | Class II | Active |
| Stryker 5000 | K935949 | FDA 510(k) | Class II | Active |
| Power-Load Cot Fastener System | K113598 | FDA 510(k) | Class II | Active |
| Stryker Operating Room Table | K940068 | FDA 510(k) | Class I | Active |
| Altrix Temperature Management Wraps | K171149 | FDA 510(k) | Class II | Active |
| Stryker I.v. Caddy Accessory Device | K920704 | FDA 510(k) | Class II | Active |
| Xpedition ™ Powered Stair Chair (625700000000) | K222818 | FDA 510(k) | Class II | Active |
| Stryker Ambulance Cot Model 6060 | K935297 | FDA 510(k) | Class II | Active |
| Stryker Eclipse Warming Stretcher | K912237 | FDA 510(k) | Class I | Active |
| Stryker 8000 Surgery Stretcher | K943864 | FDA 510(k) | Class II | Active |
| Altrix Precision Temperature Management System | K152266 | FDA 510(k) | Class II | Active |
| Stryker 5050 Strechair | K941738 | FDA 510(k) | Class I | Active |
| Stryker Dynamic Mattress System (dms) Model #2500 | K920526 | FDA 510(k) | Class I | Active |
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 17, 2006 | Z-0554-06 | — | terminated | The bed exit may not alarm as appropriate. |
| Jan 17, 2006 | Z-0555-06 | — | terminated | The bed exit may not alarm as appropriate. |
| Mar 31, 2005 | Z-0793-05 | — | terminated | Trendelenburg and reverse trendelenburg features may not function. |
| Aug 17, 2004 | Z-0023-05 | — | terminated | Locking pins may be installed backward, and cot may drop from highest to lowest position when the users are not prepared for the drop. |
| Jan 26, 2004 | Z-0526-04 | — | terminated | A potential shock hazard exists if the night light is damaged. |
| Jan 26, 2004 | Z-0524-04 | — | terminated | A potential shock hazard exists if the night light is damaged. |
| Jan 26, 2004 | Z-0525-04 | — | terminated | A potential shock hazard exists if the night light is damaged. |
| Dec 30, 2003 | Z-0304-04 | — | terminated | Users may be pinched in the siderail assembly when raising or lowering the siderail. |
| Dec 1, 2003 | Z-0267-04 | — | terminated | The user may be pinched by the siderail when raising or lowering the siderail. |
| May 1, 2003 | Z-0868-03 | — | terminated | A wire may break at the crimp and present a potential electric shock hazard. |