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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
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- FDA FEI Number
- 1825014
- DUNS Number
- —
Catalogue (1084)
Page 16 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | 1-011-02-3B | FDA UDI | Class I | Active |
| Sterling C2000 | C2000W-E480 | FDA UDI | Class II | Active |
| Chest and waist support** (pr.) | 3-010-01 | FDA UDI | Class I | Active |
| Radiographic top | 5-010-27-B | FDA UDI | Class I | Unknown |
| Skytron | 3-060-05-5S | FDA UDI | Class I | Active |
| Integrity Sterilizers | 215-CR | FDA UDI | Class II | Active |
| Skytron 48" back cover E3 | H8-300-11-A | FDA UDI | Class I | Active |
| TV-3 Handle Camera Aurora 3 and Four Series | B1-715-56 | FDA UDI | Class I | Active |
| Center Focus Handle | Sterilizable Center Focus Handle | FDA UDI | Class II | Active |
| Skytron | 1-011-16-3 | FDA UDI | Class I | Active |
| Skytron | 3-040-22-1 | FDA UDI | Class I | Active |
| Skytron | 4A-ERCS-10 Freedom | FDA UDI | Class I | Active |
| Uro Tray Only 3100 | 4-040-05-2 | FDA UDI | Class I | Active |
| Skytron | 5-010-30-D | FDA UDI | Class I | Active |
| Skytron | 4-031-02-2WS | FDA UDI | Class I | Active |
| Skytron | 3-040-22 | FDA UDI | Class I | Active |
| Skytron | 4-030-22-4S | FDA UDI | Class I | Active |
| Restraint strap | 6-010-41-X | FDA UDI | Class I | Active |
| Shoulder Chair Accessory Cart Kit | 6-020-10-1 | FDA UDI | Class I | Active |
| Skytron | F200 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-10-2B | FDA UDI | Class I | Unknown |
| Skytron | 4-090-17-1 | FDA UDI | Class I | Active |
| Sterling P/M1000 Condenser Basic 50+60 HZ | 1000-CON | FDA UDI | Class II | Active |
| Skytron | 18-443-72 | FDA UDI | Class I | Active |
| Skytron | 7-010-08-2S | FDA UDI | Class I | Active |
| I-Series Washers | I5-PRS | FDA UDI | Class II | Active |
| Skytron | 1-011-06-42 | FDA UDI | Class I | Active |
| Restraint strap | 6-010-41-VE | FDA UDI | Class I | Active |
| Skytron | 4A-VESA Freedom | FDA UDI | Class I | Active |
| Skytron Acidic Neutralizer | SKY-200SCLF-30 | FDA UDI | Class II | Active |
| Ldpe Stiffener 24" X 18" X 1/16 " | 1-011-08-22-LP | FDA UDI | Class I | Active |
| Skytron | 1-011-13-3 | FDA UDI | Class I | Active |
| Skytron | 3-060-02-3S | FDA UDI | Class I | Active |
| Skytron | 5-010-22-3B | FDA UDI | Class I | Active |
| Skytron | 1-011-10-2 | FDA UDI | Class I | Active |
| Skytron | 1-011-04-5 | FDA UDI | Class I | Active |
| Skytron | 5-010-26-B | FDA UDI | Class I | Active |
| Skytron 56" back cover | H8-300-12 | FDA UDI | Class I | Active |
| Transfer board | 4-030-20 | FDA UDI | Class I | Active |
| Skytron | 4-090-17-2 | FDA UDI | Class I | Active |
| Skytron DoVera Positioning Handle | 1950286 | FDA UDI | Class II | Active |
| Skytron | 1-011-04-4 | FDA UDI | Class I | Active |
| HyperLight Leg Section | 4-030-43 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-4 | FDA UDI | Class I | Active |
| Skytron Cart Wash Detergent | SKY-500-55 | FDA UDI | Class II | Active |
| Skytron | 4A-ERSU Freedom | FDA UDI | Class I | Active |
| Skytron 10" rail | H8-200-02 | FDA UDI | Class I | Active |
| Skytron | 4-031-01-C | FDA UDI | Class I | Active |
| Skytron | 4A-ERCA-9 Freedom | FDA UDI | Class I | Active |
| Skytron | 4A-SHC-22 Freedom | FDA UDI | Class I | Active |
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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. |