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 2 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sterling P1800 | 1800-FIX4 | FDA UDI | Class II | Active |
| Skytron | 3-060-09-1 | FDA UDI | Class I | Active |
| Skytron | 1-011-11-31 | FDA UDI | Class I | Active |
| Skytron | 3-060-09-6 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-2 | FDA UDI | Class I | Active |
| Skytron Streamline inTouch bed mount | SYK-IT | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-FLX5 | FDA UDI | Class II | Active |
| Skytron | 1-011-15-3 | FDA UDI | Class I | Active |
| Aux. Base Connector Kit | D5-060-24 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-23 | FDA UDI | Class I | Active |
| Sterling C2000 | C2000-E208 | FDA UDI | Class II | Active |
| Skytron | 5-010-21-3B | FDA UDI | Class I | Active |
| Skytron 16.5" pedal holder E3 | H8-300-13-A | FDA UDI | Class I | Active |
| UltraSlide | 3603 | FDA UDI | Class I | Active |
| Sterling P/M1000 Module | 1000-FLX5-OPTI | FDA UDI | Class II | Active |
| Patient safety strap | 6-010-50 | FDA UDI | Class I | Active |
| Skytron SCLF Multi-Enzymatic Cleaner | SKY-404SCLF-15 | FDA UDI | Class II | Active |
| Skytron Enzymatic cleaner | J5-010-02 | FDA UDI | Class II | Active |
| Skytron | 4A-CB-22 Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-08-42-LB | FDA UDI | Class I | Active |
| Skytron | 1-011-01-5 | FDA UDI | Class I | Active |
| Sterling C2000 | 2002114 | FDA UDI | Class II | Unknown |
| Skytron | 4A-FXS-BC66 Freedom | FDA UDI | Class I | Active |
| Sterling P1800 | P1800-D208S | FDA UDI | Class II | Active |
| Skytron | 1-011-05-21 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-FLX4-PLUS | FDA UDI | Class II | Active |
| Flex - da Vinci Xi Connector Kit | CS-1003-000 | FDA UDI | Class II | Active |
| Sterling Washers | P1500-FLX-BWL | FDA UDI | Class II | Active |
| Skytron Acidic Neutralizer | SKY-200SCLF-15 | FDA UDI | Class II | Active |
| Spectra Examination Light Series | AUT1W | FDA UDI | Class I | Active |
| Skytron Equipment Rail 10" E3 | H8-200-02-A | FDA UDI | Class I | Active |
| Perineal Cutout Cover W/O Velcro | 5-020-01-1 | FDA UDI | Class I | Active |
| I-Series Washers | I5-S-E | FDA UDI | Class II | Active |
| Skytron | 1-011-12-3 | FDA UDI | Class I | Active |
| Skytron | 1-011-11-51 | FDA UDI | Class I | Active |
| Skytron 22" pullout KB tray w/o mouse | H8-300-26 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-5 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-22-LB | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-AULT | FDA UDI | Class II | Active |
| Skytron | 1-011-06-43 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-2NC | FDA UDI | Class I | Active |
| Skytron | 1-011-06-4NC | FDA UDI | Class I | Active |
| Skytron SCLF Neutral pH Detergent LF 2x Conc. | SKY-400SCLF-5 | FDA UDI | Class II | Active |
| Ergon Boom Series | Ergon 3 | FDA UDI | Class I | Active |
| Skytron | 4A-EXF-12 Freedom | FDA UDI | Class I | Active |
| Skytron 10" rear rail | H8-300-07 | FDA UDI | Class I | Active |
| Skytron hook for headlight | H8-200-10 | FDA UDI | Class I | Active |
| Skytron | 5-010-19-2B | FDA UDI | Class I | Active |
| CleanStart | CSTART-8305 | FDA UDI | Class II | Active |
| Skytron | 2-060-06-2WS | FDA UDI | Class I | 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. |