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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 13 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | 1-011-11-21 | FDA UDI | Class I | Active |
| Skytron bracket for smoke-e-vac E3 | H8-300-41-A | FDA UDI | Class I | Active |
| Skytron | 4A-BHCO Freedom | FDA UDI | Class I | Active |
| Sterling C2000 | C2000W-S208 | FDA UDI | Class II | Active |
| Auxiliary base connector kit | D1-065-03 | FDA UDI | Class I | Active |
| Skytron | 4-041-01-2WS | FDA UDI | Class I | Active |
| Skytron warming cabinet | W2-652421 | FDA UDI | Class II | Active |
| Skytron Streamline Multi Care bed mount | LNT-MC | FDA UDI | Class I | Active |
| Ergon Boom Series | Ergon 2 | FDA UDI | Class II | Active |
| Radiographic top | 5-010-23-B | FDA UDI | Class I | Unknown |
| Prone Positioning Frame | 3-070-01-L | FDA UDI | Class I | Active |
| Skytron SCLF Neutral pH Detergent LF 2x Conc. | SKY-400SCLF-30 | FDA UDI | Class II | Active |
| Skytron | 1-011-07-5 | FDA UDI | Class I | Active |
| Integrity Sterilizers | 215-LC | FDA UDI | Class II | Active |
| Skytron | 4A-ERSB-13 Freedom | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-AN | FDA UDI | Class II | Active |
| Skytron | 4A-ERCA-13 Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-14-5-BOS | FDA UDI | Class I | Active |
| Skytron | 5-010-10-3B | FDA UDI | Class I | Unknown |
| Sterling C2000 | 2002206 | FDA UDI | Class II | Active |
| Skytron | 5-010-14-2B | FDA UDI | Class I | Unknown |
| Skytron | 5-010-17-B | FDA UDI | Class I | Active |
| Sterling P1000 Washer Disintector | P1000-D208E | FDA UDI | Class II | Active |
| I-Series Washers | I5-PRCS | FDA UDI | Class II | Active |
| Aurora Surgical Light Series | Aurora 3 | FDA UDI | Class II | Unknown |
| Skytron | 5-010-22-3B C3 | FDA UDI | Class I | Active |
| Skytron | 4A-EXF-24 Freedom | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-FLX5-Plus | FDA UDI | Class II | Active |
| Skytron | 1-011-06-22R | FDA UDI | Class I | Active |
| Sterling C2000 | C2000LW-E208 | FDA UDI | Class II | Active |
| Skytron | 2-010-05-4S | FDA UDI | Class I | Active |
| Skytron | 5-010-14-B | FDA UDI | Class I | Unknown |
| Skytron | 4-030-13-5SOF | FDA UDI | Class I | Active |
| Skytron LLC | 4A-PF60-ALU Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011C-02-00 | FDA UDI | Class I | Active |
| Sterling P1800 | P1800-S480E | FDA UDI | Class II | Active |
| Uro Tray | 4-040-03-2 | FDA UDI | Class I | Active |
| Armboard Extra Wide Europe | 2-060-06-EU | FDA UDI | Class I | Active |
| Skytron | 5-010-27-2B | FDA UDI | Class I | Active |
| Skytron | 4A-SHB-17 Freedom | FDA UDI | Class I | Active |
| Skytron 22" Shelf with handles E3 | 3PMSH-H | FDA UDI | Class I | Active |
| Skytron | 7-010-03-4S | FDA UDI | Class I | Active |
| Anesthesia screen | 6-020-03 | FDA UDI | Class I | Active |
| 5" Table side extension with release lever | 3-060-08 | FDA UDI | Class I | Active |
| Skytron Medi-Sheen | SKY-800-30 | FDA UDI | Class II | Active |
| Organizer | 6-020-11-1 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-43 | FDA UDI | Class I | Active |
| Softee Strap | 6-010-58 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-5NC | FDA UDI | Class I | Active |
| Aurora Surgical Light Series | Aurora LED | FDA UDI | Class II | Unknown |
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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. |