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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 17 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bar clamp | 6-030-01 | FDA UDI | Class I | Active |
| Skytron 24" back cover | H8-300-09 | FDA UDI | Class I | Active |
| Skytron | 2-060-01-4S | FDA UDI | Class I | Active |
| I-Series Washers | I5-CON | FDA UDI | Class II | Active |
| Sterling Washers | P1500-480S | FDA UDI | Class II | Active |
| Springloc Clamp | 4-090-15-3 | FDA UDI | Class I | Active |
| Skytron Flatscreen back cover E3 | 3FCM-BC | FDA UDI | Class I | Active |
| Skytron | 1-011-12-2 | FDA UDI | Class I | Active |
| Skytron P foot pedal holder | H8-200-24 | FDA UDI | Class I | Active |
| Patient Security Straps | 6-010-56 | FDA UDI | Class I | Active |
| DoVera DE12 Examination Light Series | DE12S | FDA UDI | Class I | Active |
| Skytron | GS70-1 | FDA UDI | Class I | Active |
| Skytron Mounting rails | H8-200-01-GCX | FDA UDI | Class I | Active |
| Skytron Moderate Alkaline Detergent | SKY-110SCLF-30 | FDA UDI | Class II | Active |
| Skytron | 4A-BCC-37 Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-08-53 | FDA UDI | Class I | Active |
| Skytron | F212 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron | F120 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron Sterling P1500 FLX3 Wash Rack | P1500-FLX3 | FDA UDI | Class II | Active |
| Skytron Surg-Enz Multi-Enzymatic Cleaner | J5-010-42 | FDA UDI | Class II | Active |
| Sterling M1000 | M1000-S480E | FDA UDI | Class II | Active |
| Skytron | 1-011-08-32-LB | FDA UDI | Class I | Active |
| Sterling P1800 | P1800-D480E | FDA UDI | Class II | Active |
| Skytron | 1-011-06-42-LB | FDA UDI | Class I | Active |
| Skytron | 5-010-22-3B-C1 | FDA UDI | Class I | Active |
| Skytron | 4A EXB-24 Freedom | FDA UDI | Class I | Active |
| Skytron | 4-030-61-5S | FDA UDI | Class I | Active |
| Sterling C2000 | C2000L-E208 | FDA UDI | Class II | Active |
| Sterling P1800 | 1800-FLX3 | FDA UDI | Class II | Active |
| Skytron KB tray w/mouse | H8-300-24 | FDA UDI | Class I | Active |
| Xray Top Foot/ Leg Section | 5-010-23-4B | FDA UDI | Class I | Unknown |
| Skytron | 1-011-15-2 | FDA UDI | Class I | Active |
| Skytron 22" plastic drawers | H8-300-21 | FDA UDI | Class I | Active |
| Skytron | F110 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-12-4 | FDA UDI | Class I | Active |
| Skytron | F330 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron | F320 SERIES Freedom | FDA UDI | Class I | Active |
| Camera Cover | B1-530-50-B | FDA UDI | Class II | Active |
| Skytron | 5-010-06-B | FDA UDI | Class I | Unknown |
| Skytron | 1-011-14-4-BOS | FDA UDI | Class I | Active |
| Skytron | 4A-PD-22-32 Freedom | FDA UDI | Class I | Active |
| CleanStart | CSTART-9401 | FDA UDI | Class II | Active |
| Skytron | F440 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron column extension E3 | H8-300-42-A | FDA UDI | Class I | Active |
| 18" Foot extension | 4-030-12-HD | FDA UDI | Class I | Active |
| Skytron | 4-030-43-3WS | FDA UDI | Class I | Active |
| Skytron | 1-011-02-3-BOS | FDA UDI | Class I | Active |
| Sterling M1000 | M1000-S208S | FDA UDI | Class II | Active |
| Skytron warming cabinet | W2-752421 | FDA UDI | Class II | Active |
| Skytron 16.5" drawer E3 | H8-300-18-A | 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. |