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 20 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | SES1-2 | FDA UDI | Class II | Active |
| Levitator Accessory Cart Kit | 6-020-10-2 | FDA UDI | Class I | Active |
| Knee Crutches (pr.) without clamps | 4-010-01-1 | FDA UDI | Class I | Active |
| Skytron | 5-010-21-1B | FDA UDI | Class I | Active |
| I-Series Washers | I5-PT-E | FDA UDI | Class II | Active |
| Skytron | 1-011-06-52-LB | FDA UDI | Class I | Active |
| Skytron | 1-011C-08-01 | FDA UDI | Class I | Active |
| Skytron | 4A-SHT-17 Freedom | FDA UDI | Class I | Active |
| Lift Assist Beach Chair Europe | 3-040-30-EU | FDA UDI | Class I | Active |
| Skytron | 1-011-16-4 | FDA UDI | Class I | Active |
| E-Z Grip Bar Clamp | 6-030-05-J | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-253021 | FDA UDI | Class II | Active |
| Skytron | 1-011-11-42 | FDA UDI | Class I | Active |
| Sterling Washers | P1500-MIS2 | FDA UDI | Class II | Active |
| Ergon Boom Series | Ergon 2 | FDA UDI | Class II | Active |
| Sterling Washers | P1500-WO | FDA UDI | Class II | Active |
| Skytron | 4-040-09-4SW | FDA UDI | Class I | Active |
| Skytron Carter Hand Surgery Table (Case) | 2-030-09 | FDA UDI | Class I | Active |
| Sterling Washers | P1500-208E | FDA UDI | Class II | Active |
| Skytron | 4A-BD-2-22-B Freedom | FDA UDI | Class I | Active |
| Skytron | GS70H | FDA UDI | Class I | Active |
| Skytron | 1-011-02-41 | FDA UDI | Class I | Active |
| Lucina 4 Examination Lights | LCN4-PKG4 | FDA UDI | Class I | Active |
| Sterling Washers | P1500-480E | FDA UDI | Class II | Active |
| Skytron 22" pedal holder E3 | H8-300-14-A | FDA UDI | Class I | Active |
| I-Series Washers | I3-DCD | FDA UDI | Class II | Active |
| X-Ray Top Foot/Leg Section | 5-010-21-4B | FDA UDI | Class I | Unknown |
| DoVera DE12 Examination Light Series | DE1212C | FDA UDI | Class I | Active |
| Clamp on rail | 6-070-07 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-31 | FDA UDI | Class I | Active |
| Skytron Streamline Ook Snow bed mount | UMD-OS | FDA UDI | Class I | Active |
| Skytron | 2-010-02-5S | FDA UDI | Class I | Active |
| Skytron | F340 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron Scope-Zyme Multi Enzymatic Cleaner | SKY-405SCLF-1 | FDA UDI | Class II | Active |
| Sterling Washers | P1500-RT | FDA UDI | Class II | Active |
| Cart | 6990-500 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-32-BOS | FDA UDI | Class I | Active |
| SkyVac | SVAC1 | FDA UDI | Class II | Active |
| Nautilus Surgical Light Series | Nautilus NL | FDA UDI | Class II | Unknown |
| Skytron | 3-060-09-3 | FDA UDI | Class I | Active |
| Sterling P1800 | 83300415 | FDA UDI | Class II | Active |
| Skytron Vac slide | H8-200-30-1 | FDA UDI | Class I | Active |
| Skytron | 4VSTH-CP2 Freedom | FDA UDI | Class I | Active |
| 40" Carbon Fiber Extension | 4-030-40 | FDA UDI | Class I | Active |
| Lucina 4 Examination Lights | LCN4-PKG3 | FDA UDI | Class I | Active |
| Auxiliary base connector kit | D5-017-00 | FDA UDI | Class I | Active |
| Shoulder support** (pr.) | 3-040-01 | FDA UDI | Class I | Active |
| Skytron | 4-031-02 | FDA UDI | Class I | Active |
| Skytron CO2 bottle holder | H8-200-08 | FDA UDI | Class I | Active |
| Skytron SCLF Neutral pH Detergent LF 2x Conc. | SKY-400SCLF-15 | 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. |