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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 11 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pediatric Extension | 4-030-42 | FDA UDI | Class I | Active |
| Skytron 22" pedal holder | H8-300-14 | FDA UDI | Class I | Active |
| Skytron | 1-011-01-2 | FDA UDI | Class I | Active |
| Skytron | 4A-SUH-22 Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-03-3 | FDA UDI | Class I | Active |
| Skytron | 3-040-12-5WS | FDA UDI | Class I | Active |
| Restraint strap | 6-010-41-B | FDA UDI | Class I | Active |
| Skytron ext. wingbar E3 | H8-300-04-E-A | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-ALT | FDA UDI | Class II | Active |
| Skytron | 1-011-11-43 | FDA UDI | Class I | Active |
| Skytron drawer lock set L/R diff | H8-300-25-3 | FDA UDI | Class I | Active |
| Skytron | 4-031-01-2WS | FDA UDI | Class I | Active |
| Skytron 36" back cover E3 | H8-300-10-A | FDA UDI | Class I | Active |
| Skytron | 1-011-17-4 | FDA UDI | Class I | Active |
| Skytron | 1-011-11-2 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-5 | FDA UDI | Class I | Active |
| Skytron | 1-011-11-5 | FDA UDI | Class I | Active |
| Sterling P1000 Washer Disintector | P1000-D480E | FDA UDI | Class II | Active |
| Skytron | 4-030-10-2S | FDA UDI | Class I | Active |
| X-Ray Top Head Section | 5-010-21-1B | FDA UDI | Class I | Unknown |
| Sterling P/M1000 Cover for condenser recycle | 1000-COV-RWH | FDA UDI | Class II | Active |
| Elite | 6302 | FDA UDI | Class I | Active |
| Sterling P/M1000 Anaesthesia Rack | 1000-AN | FDA UDI | Class II | Active |
| Skytron warming cabinet | W1-753021 | FDA UDI | Class II | Active |
| Sterling Washers | P1500-MT | FDA UDI | Class II | Active |
| Skytron | 5-010-19-4B | FDA UDI | Class I | Active |
| Skytron | 1-011-11-4 | FDA UDI | Class I | Active |
| Skytron | 4A-VESA-CAM Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-09-2 | FDA UDI | Class I | Active |
| Ergon Boom Series | Ergon 3 | FDA UDI | Class I | Active |
| Sterling P1800 | P1800-S208E | FDA UDI | Class II | Active |
| DoVera DE12 Examination Light Series | DE12W | FDA UDI | Class I | Active |
| Sterling P/M1000 Container Rack | 1000-CNTR-SM | FDA UDI | Class II | Active |
| Skytron | 1-011-14-3-BOS | FDA UDI | Class I | Active |
| UltraSlide | 3603H | FDA UDI | Class I | Active |
| Skytron | 1-011C-06-22 | FDA UDI | Class I | Active |
| Sterling P1000 Washer Disintector | P1000-D208S | FDA UDI | Class II | Active |
| Skytron | 1-011-02-42 | FDA UDI | Class I | Active |
| Skytron | 3-060-01-2S | FDA UDI | Class I | Active |
| Kidney Horns | 3-080-01 | FDA UDI | Class I | Active |
| 12" Carbon fiber arm surgery board for 3000 & 3003 (36" & 48" extensions) | 2-010-06 | FDA UDI | Class I | Active |
| Skytron | 4-030-43-4WS | FDA UDI | Class I | Active |
| I-Series Washers | I5-CP | FDA UDI | Class II | Active |
| I-Series Washers | I5-MIS | FDA UDI | Class II | Active |
| Skytron SCLF Neutral pH Detergent LF 2x Conc. | SKY-400SCLF-2-5 | FDA UDI | Class II | Active |
| Skytron Scope-Zyme Multi Enzymatic Cleaner | SKY-405SCLF-5 | FDA UDI | Class II | Active |
| Skytron | 4-041-01-4WS | FDA UDI | Class I | Active |
| Radiographic top | 5-010-22-B | FDA UDI | Class I | Unknown |
| Sterling P/M1000 Da Vinci Si Holder | 1000-SI85 | FDA UDI | Class II | Active |
| Skytron | 1-011-08-52 | 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. |