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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 9 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | 4A-PD-17-17 Freedom | FDA UDI | Class I | Active |
| Skytron | 2-010-05-2S | FDA UDI | Class I | Active |
| I-Series Washers | I5-PT-SE | FDA UDI | Class II | Active |
| Skytron Moderate Alkaline Detergent | SKY-110SCLF-15 | FDA UDI | Class II | Active |
| TV-3 Camera Control Unit with RS232 Connection | B1-710-59-RS | FDA UDI | Class I | Active |
| Skytron | 1-011-08-22-LB | FDA UDI | Class I | Active |
| Skytron | 4A-SKDI Freedom | FDA UDI | Class I | Active |
| Skytron | 4A-EXB-12 Freedom | FDA UDI | Class I | Active |
| Skytron Sterling Lubricant | SKY-300SCLF-2.5 | FDA UDI | Class II | Active |
| Skytron SCLF Multi-Enzymatic Cleaner | SKY-404SCLF-30 | FDA UDI | Class II | Active |
| Sterling P/M1000 Da Vinci SingleSite Holder | 1000-SS | FDA UDI | Class II | Active |
| Skytron | 4A-BD-1-22-C Freedom | FDA UDI | Class I | Active |
| Seat Section X-Ray Top | 5-010-22-3B-C | FDA UDI | Class I | Active |
| Center Focus Handle | Sterilizable Centere Focus Handle | FDA UDI | Class II | Active |
| Skytron | 5-010-14-1B | FDA UDI | Class I | Unknown |
| Skytron 36" Premium Cart E3 | 3KCP36 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-3NC | FDA UDI | Class I | Active |
| Skytron | 4A-ERCS-30 Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-02-2R | FDA UDI | Class I | Active |
| Skytron | SYK-IT-L Streamline | FDA UDI | Class I | Active |
| Skytron 16.5" pullout KB tray w/o mouse E3 | H8-300-36-A | FDA UDI | Class I | Active |
| Skytron | 4A-PD-ELO Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-02-4 | FDA UDI | Class I | Active |
| Skytron | 3-060-05-4S | FDA UDI | Class I | Active |
| Aurora Surgical Light Series | AURORA ASTRO | FDA UDI | Class II | Active |
| Sterling P1800 | P1800-S480S | FDA UDI | Class II | Active |
| Transfer Board Cover | 4-030-22-1 | FDA UDI | Class I | Active |
| Skytron | 1-011-14-2-BOS | FDA UDI | Class I | Active |
| Neuro adapter | 7-010-02-B | FDA UDI | Class I | Active |
| Sterling C2000 | 2002204 | FDA UDI | Class II | Active |
| Sterilizable Handle for DoVera DE12 Examination Light Series | Z180045 | FDA UDI | Class II | Active |
| Skytron Cart Wash Detergent | SKY-500-5 | FDA UDI | Class II | Active |
| Skytron Sterling Lubricant | SKY-300SCLF-30 | FDA UDI | Class II | Active |
| I-Series Washers | I5-S-SE | FDA UDI | Class II | Active |
| Skytron Medi-Sheen | SKY-800-15 | FDA UDI | Class II | Active |
| Sterling C2000 | 2002101 | FDA UDI | Class II | Unknown |
| Skytron | AIR SAFE | FDA UDI | Class II | Active |
| Skytron | 4-031-03 | FDA UDI | Class I | Active |
| Skytron | 5-010-02-1B | FDA UDI | Class I | Active |
| Skytron | 1-011-02-21 | FDA UDI | Class I | Active |
| Skytron | 5-010-05-3B | FDA UDI | Class I | Unknown |
| Skytron Medi-Sheen | SKY-800-55 | FDA UDI | Class II | Active |
| X-Ray Back Section | 5-010-09-2B | FDA UDI | Class I | Unknown |
| Skytron | 4A-SHF-48 Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-27-4B | FDA UDI | Class I | Active |
| Skytron KiNEO Cart docking adapter E3 | 3KC-DD | FDA UDI | Class I | Active |
| Skytron | 3-060-02-5S | FDA UDI | Class I | Active |
| Sterling P/M1000 Flexible Rack | 1000-FIX4 | FDA UDI | Class II | Active |
| Skytron IV pole spacer | H8-200-06-1 | FDA UDI | Class I | Active |
| Skytron | 1-011-01-4 | 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. |