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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
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- —
- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 1825014
- DUNS Number
- —
Catalogue (1084)
Page 14 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | 4-031-02-4WS | FDA UDI | Class I | Active |
| Radiographic top | 5-010-19-B | FDA UDI | Class I | Unknown |
| Skytron Acidic Neutralizer | SKY-200-1 | FDA UDI | Class II | Active |
| Skytron | 1-011-04-23 | FDA UDI | Class I | Active |
| Skytron | 1-011-15-4 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-22 | FDA UDI | Class I | Active |
| Sterling Washers | P1500-B4L-BWL | FDA UDI | Class II | Active |
| Anesthesia screen | 6-020-02-1 | FDA UDI | Class I | Active |
| Skytron Streamline Progressa bed mount | HRC-PRO | FDA UDI | Class I | Active |
| I-Series Washers | I3-PR | FDA UDI | Class II | Active |
| Skytron | 4-031-03-4WS | FDA UDI | Class I | Active |
| Sterling M1000 | M1000-D208E | FDA UDI | Class II | Active |
| Head end uro tray adapter | 4-040-06-1 | FDA UDI | Class I | Active |
| Auxiliary base connector kit | D5-032-00 | FDA UDI | Class I | Active |
| Skytron | 3-040-12-4WS | FDA UDI | Class I | Active |
| Skytron | QUIKLINK | FDA UDI | Class II | Active |
| SkyVac | SES1 | FDA UDI | Class II | Active |
| CleanStart | CSTART-9205 | FDA UDI | Class II | Active |
| Skytron 22" shelf | PMSH | FDA UDI | Class I | Active |
| TV-3 Camera Control Unit Aurora II, 3, and Four Series | B1-710-59 | FDA UDI | Class I | Unknown |
| Skytron | 1-011-03-5 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-5 | FDA UDI | Class I | Active |
| Sterling M1000 | M1000-S480S | FDA UDI | Class II | Active |
| Sterling C2000 | C2000L-E480 | FDA UDI | Class II | Active |
| Sterling P/M1000 High speed module, 480V | 1000-HSM-480 | FDA UDI | Class II | Active |
| Skytron 16.5" nitro faceplate | H8-300-16-2 | FDA UDI | Class I | Active |
| Skytron | 5-010-23-1B | FDA UDI | Class I | Active |
| Skytron | 2-010-07-3WS | FDA UDI | Class I | Active |
| Lucina Control Wand | B5-014-39 | FDA UDI | Class I | Active |
| CleanStart | CSTART-9605 | FDA UDI | Class II | Active |
| Skytron | 4A-EXU-12 Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-18-B | FDA UDI | Class I | Unknown |
| Skytron | 4A-SHB-22 Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-08-32 | FDA UDI | Class I | Active |
| Skytron | 4-030-40-3S | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-653027 | FDA UDI | Class II | Active |
| Skytron 22" pullout KB tray w/mouse | H8-300-27 | FDA UDI | Class I | Active |
| Skytron | 5-010-19-B | FDA UDI | Class I | Active |
| Flex | FLEX-CT6 | FDA UDI | Class I | Active |
| Skytron | 1-011-17-2 | FDA UDI | Class I | Active |
| Sterling P/M1000 Rack | 1000-BB-250 | FDA UDI | Class II | Active |
| Sterling Washers | P1500-AN | FDA UDI | Class II | Active |
| Skytron | 4-041-01-3WS | FDA UDI | Class I | Active |
| Foot rests for split leg (pr.) | 4-030-04 | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-252421 | FDA UDI | Class II | Active |
| SkyVision | Ascend Eco | FDA UDI | Class I | Active |
| Skytron | 4-030-40-4S | FDA UDI | Class I | Active |
| Skytron | 4-031-04 | FDA UDI | Class I | Active |
| E-Z Grip Bar Clamp | 6-030-05 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-HSM-480 | FDA UDI | Class II | Active |
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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. |