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Sign in to claim this brandSkytron, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1825014
- DUNS Number
- —
Catalogue (1084)
Page 10 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | 4-030-10-B | FDA UDI | Class I | Active |
| Skytron | 1-011-03-4 | FDA UDI | Class I | Active |
| Skytron Moderate Alkaline Detergent | SKY-110SCLF-1 | FDA UDI | Class II | Active |
| Skytron | 4A-PUS-17 Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-21-2B | FDA UDI | Class I | Active |
| Skytron Smoke Evacuation | ELVV220 | FDA UDI | Class II | Active |
| Skytron warming cabinet | W2-652427 | FDA UDI | Class II | Active |
| Skytron Scope-Zyme Multi Enzymatic Cleaner | SKY-405SCLF-15 | FDA UDI | Class II | Active |
| Skytron | 4-030-10-3WS | FDA UDI | Class I | Active |
| Hyperlight Transfer Board | 4-030-44 | FDA UDI | Class I | Active |
| X-Ray Head Section | 5-010-02-1B | FDA UDI | Class I | Unknown |
| Skytron | 1-011-06-21 | FDA UDI | Class I | Active |
| Skytron | 4A-BUD Freedom | FDA UDI | Class I | Active |
| Skytron | 3-041-01 | FDA UDI | Class I | Active |
| Skytron 24" back cover E3 | H8-300-09-A | FDA UDI | Class I | Active |
| Skytron | 1-011-13-4 | FDA UDI | Class I | Active |
| Radiographic top | 5-010-21-B | FDA UDI | Class I | Unknown |
| Skytron | 4A-ERBA Freedom | FDA UDI | Class I | Active |
| CleanStart | CSTART-9625 | FDA UDI | Class II | Active |
| Sterling P/M1000 Flexible Rack for washing in 4 levels | 1000-FLX4 | FDA UDI | Class II | Active |
| Skytron vac slide rail mt | H8-200-07 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-CON | FDA UDI | Class II | Active |
| Skytron | 1-011-06-3-BOS | FDA UDI | Class I | Active |
| Skytron | F222 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron | 4A-CS-49 Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-21-BC | FDA UDI | Class I | Active |
| CleanStart | CSTART-7125 | FDA UDI | Class II | Active |
| Skytron front rail 10" E3 | H8-300-08-A | FDA UDI | Class I | Active |
| Skytron | 4-030-44-3WS | FDA UDI | Class I | Active |
| Skytron Cart Rinse and Drying Agent | SKY-600-5 | FDA UDI | Class II | Active |
| SkyVision | SDS | FDA UDI | Class I | Active |
| CleanStart | CSTART-8501 | FDA UDI | Class II | Active |
| Lucina 4 Examination Lights | LCN4-PKG1 | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-252427 | FDA UDI | Class II | Active |
| Skytron | 4A-HAB Freedom | FDA UDI | Class I | Active |
| Sterling C2000 | 2002205 | FDA UDI | Class II | Active |
| Skytron | 4A-CA-UB Freedom | FDA UDI | Class I | Active |
| Kub Board | 4-040-09-7 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-FLX-SH | FDA UDI | Class II | Active |
| Skytron Sterling Lubricant | SKY-300SCLF-15 | FDA UDI | Class II | Active |
| Spectra Examination Light Series | AUT1B | FDA UDI | Class I | Active |
| Skytron | 1-011-08-33 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-3B | FDA UDI | Class I | Active |
| Skytron | 4-041-01 | FDA UDI | Class I | Active |
| Uro drain tray with mounting brackets | 4-040-07 | FDA UDI | Class I | Active |
| Skytron | 5-010-02-2B | FDA UDI | Class I | Unknown |
| Aurora Surgical Light Series | Aurora II | FDA UDI | Class II | Unknown |
| Skytron | 4-041-01-5WS | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-362421 | FDA UDI | Class II | Active |
| Skytron 16.5" pedal holder | H8-300-13 | FDA UDI | Class I | Active |
Related Companies
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FDA Recalls (2)
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 |
|---|---|---|---|---|
| Aug 1, 2023 | Z-2469-2023 | — | open, classified | When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode. |
| Aug 1, 2023 | Z-2470-2023 | — | open, classified | When the control of the operating table was used in Bluetooth mode, the operating table continued moving even after releasing the button on the control. Originally, the root cause was thought to be confined to Bluetooth/wireless communications between the control pendant and the surgical table. However, during investigation, Mizuho discovered that the failure could be replicated even in wired mode if communication between the pendant and table were somehow interrupted. The root cause appears to be: if communication between the controller and table is interrupted while a button is pressed, the table does not know if/when a button is released. This occurs in wireless or wired mode. |