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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 1 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron small VST clamp E3 | H8-300-53-A | FDA UDI | Class I | Active |
| Skytron | 4A-PF37 Freedom | FDA UDI | Class I | Active |
| Skytron | 4A-EXU-24 Freedom | FDA UDI | Class I | Active |
| Skytron IV pole extension | H8-200-59 | FDA UDI | Class I | Active |
| Skytron Acidic Neutralizer | SKY-200-15 | FDA UDI | Class II | Active |
| X-Ray Top Set | 5-010-05-B | FDA UDI | Class I | Unknown |
| Skytron | 4A-BRAD Freedom | FDA UDI | Class I | Active |
| Skytron SCLF Multi-Enzymatic Cleaner | SKY-404SCLF-1 | FDA UDI | Class II | Active |
| Uro drain tray | 4-040-03 | FDA UDI | Class I | Active |
| CleanStart | CSTART-8505 | FDA UDI | Class II | Active |
| Springloc Clamp Jpn | 4-090-15-JPN | FDA UDI | Class I | Active |
| Skytron 16.5" Shelf with stainless steel top E3 | 3KMSHSS | FDA UDI | Class I | Active |
| Skytron | 4A-SUH-17 Freedom | FDA UDI | Class I | Active |
| Skytron Cart Rinse and Drying Agent | SKY-600-55 | FDA UDI | Class II | Active |
| Sterling Washers | P1500-MIS1 | FDA UDI | Class II | Active |
| Skytron Cart Rinse and Drying Agent | SKY-600-1 | FDA UDI | Class II | Active |
| Skytron | 4-030-13 | FDA UDI | Class I | Active |
| Skytron Lubricant | J5-010-32 | FDA UDI | Class II | Active |
| Skytron | 5-010-09-4B | FDA UDI | Class I | Active |
| Patient Safety Strap | 6-010-55 | FDA UDI | Class I | Active |
| Skytron | SMOKE-E-VAC | FDA UDI | Class II | Active |
| Sterling P/M1000 Rack | 1000-BB-125 | FDA UDI | Class II | Active |
| E-Z Lift Assist Beach Chair | 3-040-30 | FDA UDI | Class I | Active |
| Sterling C2000 | C2000-S480 | FDA UDI | Class II | Active |
| Sterling P/M1000 High speed module | 1000-HSM | FDA UDI | Class II | Active |
| Transfer Board | 4-030-22 | FDA UDI | Class I | Active |
| Skytron | 4-031-01-3WS | FDA UDI | Class I | Active |
| Skytron Modulus II tether | H9-200-09 | FDA UDI | Class I | Active |
| Skytron | 1-011-05-4 | FDA UDI | Class I | Active |
| Skytron | F410 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron warming cabinet | W2-753021 | FDA UDI | Class II | Active |
| Center Focus Handle | B1-530-40 | FDA UDI | Class II | Active |
| Skytron | 4-040-09-3S | FDA UDI | Class I | Active |
| Skytron | 1-011-08-42 | FDA UDI | Class I | Active |
| support rod | 6-030-05-HD | FDA UDI | Class I | Active |
| Transfer board | 4-030-18 | FDA UDI | Class I | Active |
| Ergon Boom Series | Ergon 3 | FDA UDI | Class II | Active |
| Skytron | 4-030-43-2WS | FDA UDI | Class I | Active |
| Skytron Neutral pH Detergent Low Foam | SKY-400-15 | FDA UDI | Class II | Active |
| OB hand grips** (pr.) | 2-050-01 | FDA UDI | Class I | Active |
| C & W Support | 3-010-01-0 | FDA UDI | Class I | Active |
| Skytron | 1-011-11-41 | FDA UDI | Class I | Active |
| X-Ray Top Set | 5-010-16 | FDA UDI | Class I | Active |
| Skytron | 4A-ERSH-32 Freedom | FDA UDI | Class I | Active |
| Sterling P/M1000 Container Rack | 1000-CNTR-MED | FDA UDI | Class II | Active |
| Essentia | 1602 | FDA UDI | Class I | Unknown |
| support rod | 6-040-07-HD | FDA UDI | Class I | Active |
| Skytron | 5-010-16-3B | FDA UDI | Class I | Active |
| Skytron | 2-010-07-5WS | FDA UDI | Class I | Active |
| Universal side rail clamp | 6-040-01 | 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. |