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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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- —
- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 1825014
- DUNS Number
- —
Catalogue (1084)
Page 4 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | 3-040-33-1 | FDA UDI | Class I | Active |
| Skytron Basket | H8-200-09 | FDA UDI | Class I | Active |
| Skytron angle vac slide | H8-211-01 | FDA UDI | Class I | Active |
| Ortho Trax System (cart priced separately). | 6990 | FDA UDI | Class I | Active |
| Sterling M1000 | M1000-S208E | FDA UDI | Class II | Active |
| Skytron | 3-041-03 | FDA UDI | Class I | Active |
| Skytron | 5-010-14-3B | FDA UDI | Class I | Unknown |
| Springloc Clamp | 4-090-15 | FDA UDI | Class I | Active |
| Sterling P/M1000 Condenser High speed 60 Hz | 1000-CON-HSM | FDA UDI | Class II | Active |
| Flexfit 600 Stirrups | 4-090-06 | FDA UDI | Class I | Active |
| Sterling P/M1000 Da Vinci Si Holder | 1000-XI8 | FDA UDI | Class II | Active |
| Skytron | 4-031-01-4WS | FDA UDI | Class I | Active |
| Table side extension | 3-060-04 | FDA UDI | Class I | Active |
| I-Series Washers | I5-3LR | FDA UDI | Class II | Active |
| Skytron | 1-011-01-22 | FDA UDI | Class I | Active |
| Skytron | 1-011-11-3 | FDA UDI | Class I | Active |
| Skytron | 4-090-16 | FDA UDI | Class I | Active |
| Skytron | 5-010-02-4B | FDA UDI | Class I | Unknown |
| Skytron rail set for drawer E3 | H8-300-37-A | FDA UDI | Class I | Active |
| Flex Fin Stirrups | 4-090-04-95 | FDA UDI | Class I | Active |
| Skytron | 1-011C-08-02 | FDA UDI | Class I | Active |
| Sterling P/M1000 MIC Module | 1000-MICM-FLX5 | FDA UDI | Class II | Active |
| Skytron | 4A-SDOB Freedom | FDA UDI | Class I | Active |
| Sterling P/M1000 Flexible Rack for washing in 5 levels | 1000-FLX5 | FDA UDI | Class II | Active |
| Sterling Washers | P1500-FLX2 | FDA UDI | Class II | Active |
| Skytron | 4-090-17-3 | FDA UDI | Class I | Active |
| Skytron | 1-011-04-22 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-AHDTC | FDA UDI | Class II | Active |
| Skytron | 4A-BCC-49 Freedom | FDA UDI | Class I | Active |
| Tri-camp | 6-040-03 | FDA UDI | Class I | Active |
| Auto Wash | J5-010-13 | FDA UDI | Class II | Active |
| Sterling P/M1000 Manual loading cart | 1000-MC | FDA UDI | Class II | Active |
| Skytron | 5-010-19-3B | FDA UDI | Class I | Active |
| Skytron | 1-011-06-2 | FDA UDI | Class I | Active |
| Skytron dual CO2 bottle holder E3 | H8-300-23-A | FDA UDI | Class I | Active |
| Skytron | 5-010-18-4B | FDA UDI | Class I | Unknown |
| Lower Back Section | 3-040-24 | FDA UDI | Class I | Active |
| Foot Control 3602 / 6702 | 18-443-15 | FDA UDI | Class I | Active |
| Ergon Boom Series | Ergon 2 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-4 | FDA UDI | Class I | Active |
| Skytron | 4A-BD-2-22-C Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-15-3B | FDA UDI | Class I | Unknown |
| Skytron dual Argon holder | H8-300-28 | FDA UDI | Class I | Active |
| Lateral Brace for shoulder positioners** | 3-010-04 | FDA UDI | Class I | Active |
| Foot Control 3502 / 6302 | 18-443-10 | FDA UDI | Class I | Active |
| Skytron | 4-031-03-2WS | FDA UDI | Class I | Active |
| Shoulder Chair | 3-040-32-EU | FDA UDI | Class I | Active |
| Sterling C2000 | C2000LW-S480 | FDA UDI | Class II | Active |
| Restraint Strap | 6-010-52 | FDA UDI | Class I | Active |
| Skytron | 1-011-04-43 | 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. |