Is this your brand? Sign in to claim ownership.
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 8 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron 22" drawer E3 | H8-300-19-A | FDA UDI | Class I | Active |
| Instrument Tray No Clamp | 6-060-01-1 | FDA UDI | Class I | Active |
| Head End Uro Tray Adapter | 4-040-11 | FDA UDI | Class I | Active |
| Sterling C2000 | 2001017 | FDA UDI | Class II | Active |
| Skytron | 4A-BD-1-22-B Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-02-3B | FDA UDI | Class I | Unknown |
| Top Section Custom Extended Length | 5-010-22-3B-C1 | FDA UDI | Class I | Active |
| Skytron 50" back cover | H8-200-12 | FDA UDI | Class I | Active |
| I-Series Washers | I5-TCD | FDA UDI | Class II | Active |
| Skytron | 4A-FPH-22 Freedom | FDA UDI | Class I | Active |
| Skytron | 4A-HAS Freedom | FDA UDI | Class I | Active |
| Premium Locking Armboard | 2-010-09 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-22-I | FDA UDI | Class I | Active |
| Skytron Streamline system with wide wing | ISS-WW | FDA UDI | Class I | Active |
| CleanStart | CSTART-9825 | FDA UDI | Class II | Active |
| X-Ray Top Set | 5-010-06 | FDA UDI | Class I | Active |
| Skytron | 3-060-09-2 | FDA UDI | Class I | Active |
| Skytron | 1-011-05-2 | FDA UDI | Class I | Active |
| Skytron 22" pullout KB tray w/mouse E3 | H8-300-27-A | FDA UDI | Class I | Active |
| Sterling Washers | P1500-FIX5L | FDA UDI | Class II | Active |
| I-Series Washers | I5-4LR | FDA UDI | Class II | Active |
| Skytron warming cabinet | W2-653027 | FDA UDI | Class II | Active |
| Skytron | 4A-HAC Freedom | FDA UDI | Class I | Active |
| Skytron warming cabinet | W2-753027 | FDA UDI | Class II | Active |
| Integrity Sterilizers | INTEGRITY 175SG | FDA UDI | Class II | Active |
| Ergon Boom Series | Ergon 2 | FDA UDI | Class I | Active |
| Skytron | 1-011-05-22 | FDA UDI | Class I | Active |
| Skytron | 4A-IVE-W Freedom | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-FLX4 | FDA UDI | Class II | Active |
| Sterling P1800 | 1800-HSM-208 | FDA UDI | Class II | Active |
| Rail Clamp | 6-030-06 | FDA UDI | Class I | Active |
| I-Series Washers | I3-TC | FDA UDI | Class II | Active |
| Skytron rear rail 10" E3 | H8-300-07-A | FDA UDI | Class I | Active |
| Skytron | 5-010-21-3NCB | FDA UDI | Class I | Active |
| Skytron 56" back cover E3 | H8-300-12-A | FDA UDI | Class I | Active |
| CleanStart | CSTART-9225 | FDA UDI | Class II | Active |
| Skytron | 4-030-13-2S | FDA UDI | Class I | Active |
| Sterling P1800 | P1800-D208E | FDA UDI | Class II | Active |
| Skytron | 1-011-12-33 | FDA UDI | Class I | Active |
| Clamp On Rail | 6-070-07-3 | FDA UDI | Class I | Active |
| Sterling C2000 | C2000W-S480 | FDA UDI | Class II | Active |
| Skytron | 5-010-02-B | FDA UDI | Class I | Unknown |
| Sterling P/M1000 Condenser recycle water and heat 60 Hz | 1000-CON-RWH | FDA UDI | Class II | Active |
| Skytron | 3-040-12-2WS | FDA UDI | Class I | Active |
| EZ Slide | 3503 | FDA UDI | Class I | Active |
| X-Ray Top Back Section | 5-010-09-2BC | FDA UDI | Class I | Active |
| Nissen strap set | 6-010-51 | FDA UDI | Class I | Active |
| Sterling P1000 Washer Disintector | P1000-D480S | FDA UDI | Class II | Active |
| I-Series Washers | I5-APR | FDA UDI | Class II | Active |
| Sterling P1800 | 1800-CNTR-SM | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |