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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 15 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sterling P1800 | P1800-S208S | FDA UDI | Class II | Active |
| Skytron warming cabinet | W1-752427 | FDA UDI | Class II | Active |
| Sterling P1800 | 8300173 | FDA UDI | Class II | Active |
| Skytron | 1-011-06-54 | FDA UDI | Class I | Active |
| Skytron Beach Chair | 3-040-32 | FDA UDI | Class I | Active |
| Lucina 4 Examination Lights | LCN4-PKG2 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-32 | FDA UDI | Class I | Active |
| Skytron | 1-011-07-2 | FDA UDI | Class I | Active |
| Skytron 22" plastic drawers E3 | H8-300-21-A | FDA UDI | Class I | Active |
| Skytron | 1-011-02-52 | FDA UDI | Class I | Active |
| Skytron Acidic Neutralizer | SKY-200-5 | FDA UDI | Class II | Active |
| Light Weight Standard Armboard | 2-010-07-EU | FDA UDI | Class I | Active |
| SkyVision Ascend | Ascend | FDA UDI | Class I | Active |
| Skytron drawer lock set L/R same | H8-300-25-4 | FDA UDI | Class I | Active |
| Skytron 16.5" shelf | KMSH | FDA UDI | Class I | Active |
| Skytron Lubricant | J5-010-08 | FDA UDI | Class II | Active |
| Skytron | 1-011-08-2F | FDA UDI | Class I | Active |
| Skytron Medi-Sheen | SKY-800-1 | FDA UDI | Class II | Active |
| Skytron | 6-020-10-9 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-2 | FDA UDI | Class I | Active |
| Skytron | 5-010-16-B | FDA UDI | Class I | Active |
| Skytron | 1-011-08-3 | FDA UDI | Class I | Active |
| Skytron | 5-010-27-B | FDA UDI | Class I | Active |
| Skytron 2A/2B/2C tether | H9-200-07 | FDA UDI | Class I | Active |
| Skytron | 2-060-01-3WS | FDA UDI | Class I | Active |
| Skytron | 4A-CS-61 Freedom | FDA UDI | Class I | Active |
| Sterling Washers | P1500-FLX-KB | FDA UDI | Class II | Active |
| Precision HD Camera for Lumos | B1-725-56 | FDA UDI | Class I | Active |
| Aurora Surgical Light Series | Aurora Four | FDA UDI | Class II | Active |
| Skytron dual CO2 bottle holder | H8-300-23 | FDA UDI | Class I | Active |
| Uro Tray Bracket | 4-040-07-1 | FDA UDI | Class I | Active |
| Sterling P/M1000 Da Vinci Xi Stapler Holder | 1000-XIST | FDA UDI | Class II | Active |
| Skytron | 5-010-23-4B | FDA UDI | Class I | Active |
| CleanStart | CSTART-9805 | FDA UDI | Class II | Active |
| Skytron 20" front rail E3 | H8-300-34-A | FDA UDI | Class I | Active |
| Skytron | 3-060-09-4 | FDA UDI | Class I | Active |
| Skytron | 1-011-16-2 | FDA UDI | Class I | Active |
| Skytron | 4A-IVE-C Freedom | FDA UDI | Class I | Active |
| Skytron | 3-060-09-5 | FDA UDI | Class I | Active |
| X-Ray Top | 4-030-10-2B | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-DVXI | FDA UDI | Class II | Active |
| Skytron | 5-010-22-3B-C | FDA UDI | Class I | Active |
| Skytron Sterling Lubricant | SKY-300SCLF-5 | FDA UDI | Class II | Active |
| I-Series Washers | I5-5LR | FDA UDI | Class II | Active |
| Skytron | 1-011-07-4 | FDA UDI | Class I | Active |
| Skytron General Tilt Seat | 3-040-12 | FDA UDI | Class I | Active |
| Skytron | 4A-CB-17 Freedom | FDA UDI | Class I | Active |
| Angle block adapter | 9-050-02 | FDA UDI | Class I | Active |
| Skytron | 1-011-11-23 | FDA UDI | Class I | Active |
| SkyVision | LINX 300 | FDA UDI | Class I | 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. |