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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 5 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | 1-011-12-32 | FDA UDI | Class I | Active |
| Ergon Boom Series | Ergon 2 | FDA UDI | Class I | Active |
| Skytron Streamline Big Wheel Stretcher mount | SYK-PBW | FDA UDI | Class I | Active |
| Skytron | 1-011-06-3BC | FDA UDI | Class I | Active |
| Skytron double can holder | H8-300-35 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-33 | FDA UDI | Class I | Active |
| X-Ray Top Set | 5-010-26-B | FDA UDI | Class I | Unknown |
| CleanStart | CSTART-7701 | FDA UDI | Class II | Active |
| Skytron Streamline Total Care bed mount | HRC-TC | FDA UDI | Class I | Active |
| Standard Armboard | 2-010-07 | FDA UDI | Class I | Active |
| Skytron 22" drawer | H8-300-19 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-2C | FDA UDI | Class I | Active |
| Skytron rear handles | H8-300-15 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-33 | FDA UDI | Class I | Active |
| Integrity Sterilizers | INTEGRITY 175 | FDA UDI | Class II | Active |
| Skytron | 1-011-17-3 | FDA UDI | Class I | Active |
| Skytron | 1-011-04-2 | FDA UDI | Class I | Active |
| Restraint Strap | 6-010-41-V | FDA UDI | Class I | Active |
| Sterling P/M1000 MIC Rack | 1000-MIC-WN | FDA UDI | Class II | Active |
| Skytron camera mount E3 | H8-300-33-A | FDA UDI | Class I | Active |
| Skytron Hook for Headlight E3 | H8-200-10-A | FDA UDI | Class I | Active |
| Skytron 32" Shelf with handles E3 | 3XMSH-H | FDA UDI | Class I | Active |
| Skytron | 4-030-10-4S | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-MC | FDA UDI | Class II | Active |
| Skytron | 4A-FXS-BC72 Freedom | FDA UDI | Class I | Active |
| Nylon Restraint Belt | 6-010-57 | FDA UDI | Class I | Active |
| Skytron dual Argon holder E3 | H8-300-28-A | FDA UDI | Class I | Active |
| Skytron 60" back cover | H8-200-13 | FDA UDI | Class I | Active |
| Skytron | 4-030-04-2S | FDA UDI | Class I | Active |
| Skytron Sterling Lubricant | SKY-300SCLF-1 | FDA UDI | Class II | Active |
| Skytron | 1-011-08-3R | FDA UDI | Class I | Active |
| Organizer | 6-020-11 | FDA UDI | Class I | Active |
| Integrity Sterilizers | 215-LC-CONV | FDA UDI | Class II | Active |
| Skytron | 1-011-11-52 | FDA UDI | Class I | Active |
| Skytron | F420 SERIES Freedom | FDA UDI | Class I | Active |
| CleanStart | CSTART-9801 | FDA UDI | Class II | Active |
| Skytron | F221 SERIES Freedom | FDA UDI | Class I | Active |
| Ergon Boom Series | Ergon 3 | FDA UDI | Class II | Active |
| Skytron | 5-010-10-B | FDA UDI | Class I | Unknown |
| Sterling C2000 | C2000-S208 | FDA UDI | Class II | Active |
| Skytron | 1-011-06-3 | FDA UDI | Class I | Active |
| Skytron 22" plastic drawer E3 | H8-300-20-A | FDA UDI | Class I | Active |
| Transfer Board Support Rod | 4-030-22-2 | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-362427 | FDA UDI | Class II | Active |
| Sterling P/M1000 Condenser High speed 60 Hz, 480V | 1000-CON-480HSM | FDA UDI | Class II | Active |
| Skytron rear handles E3 | H8-300-15-A | FDA UDI | Class I | Active |
| Skytron | 4A-PF32 Freedom | FDA UDI | Class I | Active |
| Skytron K foot pedal holder | H8-200-23 | FDA UDI | Class I | Active |
| Skytron | 1-011-07-21 | FDA UDI | Class I | Active |
| Skytron Acidic Neutralizer | SKY-200SCLF-2.5 | 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. |