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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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- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
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- FDA FEI Number
- 1825014
- DUNS Number
- —
Catalogue (1084)
Page 18 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Universal Side Rail Clamp | 6-040-12 | FDA UDI | Class I | Active |
| Skytron Acidic Neutralizer | SKY-200SCLF-5 | FDA UDI | Class II | Active |
| Body Restraint | 6-010-54 | FDA UDI | Class I | Active |
| Skytron | F350 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron | SkyVac | FDA UDI | Class II | Active |
| Skytron 4 Hook IV tree E3 | H8-200-06-A | FDA UDI | Class I | Active |
| Ergon Boom Series | Ergon 2 | FDA UDI | Class I | Active |
| Skytron | 2-060-06-P | FDA UDI | Class I | Active |
| Skytron 36" back cover | H8-300-10 | FDA UDI | Class I | Active |
| Skytron | 4-030-61-4S | FDA UDI | Class I | Active |
| Knee Crutch W/Foot Support | 4-010-03-4 | FDA UDI | Class I | Active |
| Skytron | 1-011-17-5 | FDA UDI | Class I | Active |
| Skytron | 1-011-01-3 | FDA UDI | Class I | Active |
| Skytron | 1-011-10-22 | FDA UDI | Class I | Active |
| Skytron | 4-030-01-3SOF | FDA UDI | Class I | Active |
| Skytron drawer lock set | H8-300-25 | FDA UDI | Class I | Active |
| Sterling P/M1000 Flexible Rack | 1000-FIX5 | FDA UDI | Class II | Active |
| Skytron SCLF Multi-Enzymatic Cleaner | SKY-404SCLF-2.5 | FDA UDI | Class II | Active |
| Skytron | 3-060-05-3S | FDA UDI | Class I | Active |
| Skytron front rail 10" | H8-300-08 | FDA UDI | Class I | Active |
| Skytron | 4-031-03-5WS | FDA UDI | Class I | Active |
| Sterling P/M1000 Basket | 1000-FLX-BWL | FDA UDI | Class II | Active |
| Tri Clamp | 6-040-04 | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-363027 | FDA UDI | Class II | Active |
| Premium Locking Armboard Eu | 2-010-09-EU | FDA UDI | Class I | Active |
| Skytron Moderate Alkaline Detergent | SKY-110SCLF-55 | FDA UDI | Class II | Active |
| Skytron VBA wraparound rail | H8-200-03 | FDA UDI | Class I | Active |
| X-Ray Top Set | 5-010-28-B | FDA UDI | Class I | Unknown |
| Pivoting carbon fiber clamp-on armboard | 2-060-04 | FDA UDI | Class I | Active |
| Skytron | 5-010-16 | FDA UDI | Class I | Active |
| Skytron | 2-010-07-4WS | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-FIX6 | FDA UDI | Class II | Active |
| Camera | C-DM | FDA UDI | Class I | Active |
| Sterling P/M1000 Da Vinci Rack | 1000-DVXISI | FDA UDI | Class II | Active |
| EZ grip bar clamp | 6-030-05-1 | FDA UDI | Class I | Active |
| Skytron 32" Shelf E3 | 3XMSH | FDA UDI | Class I | Active |
| Skytron | 5-010-19-1 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-52-LB | FDA UDI | Class I | Active |
| Lumos Surgical Light Series | Lumos L5 | FDA UDI | Class II | Active |
| Skytron | 2-060-01-2S | FDA UDI | Class I | Active |
| Sterling M1000 | M1000-D480E | FDA UDI | Class II | Active |
| Sterling C2000 | 2006664 | FDA UDI | Class II | Active |
| X-Ray Top Set | 5-010-09-B | FDA UDI | Class I | Unknown |
| Sterling P/M1000 Flexible Rack | 1000-FLX3 | FDA UDI | Class II | Active |
| Skytron Moderate Alkaline Detergent | SKY-110SCLF-2.5 | FDA UDI | Class II | Active |
| Skytron | 7-010-08-3S | FDA UDI | Class I | Active |
| Catheter extension | 6-020-09 | FDA UDI | Class I | Active |
| Sterling C2000 | C2000L-S208 | FDA UDI | Class II | Active |
| Sterling P/M1000 Condenser recycle water and heat 60 Hz, 480V | 1000-CON-480RWH | FDA UDI | Class II | Active |
| Sterling C2000 | 2002121 | 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. |