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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
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- EUDAMED SRN
- —
- FDA FEI Number
- 1825014
- DUNS Number
- —
Catalogue (1084)
Page 6 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sterling P/M1000 Support | 1000-FLX-SH | FDA UDI | Class II | Active |
| Skytron DoVera Positioning Handle | 1950288 | FDA UDI | Class II | Active |
| Skytron | 3-060-05-2S | FDA UDI | Class I | Active |
| Head end uro tray adapter | 4-040-06-3 | FDA UDI | Class I | Active |
| Skytron SCLF Multi-Enzymatic Cleaner | SKY-404SCLF-5 | FDA UDI | Class II | Active |
| Skytron | 4A-BHUA Freedom | FDA UDI | Class I | Active |
| Skytron 48" Premium Cart E3 | 3KCP48 | FDA UDI | Class I | Active |
| F101 Series Mount With 1 Lf Arm | F101 Series | FDA UDI | Class I | Active |
| 40" Carbon Fiber Extension | 4-030-40-J | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-253027 | FDA UDI | Class II | Active |
| Skytron | 1-011-12-5 | FDA UDI | Class I | Active |
| Skytron Acidic Neutralizer | SKY-200SCLF-55 | FDA UDI | Class II | Active |
| Sterling Washers | P1500-FLX4 | FDA UDI | Class II | Active |
| Skytron | 4A-FXS-BC60 Freedom | FDA UDI | Class I | Active |
| Sterling P1800 | 2902850 | FDA UDI | Class II | Active |
| Argos II/AR24 Control Wand | B5-012-39 | FDA UDI | Class I | Active |
| Skytron wingbar | H8-300-04 | FDA UDI | Class I | Active |
| Flex Surgical Instrument Washer | CS-0040-000 | FDA UDI | Class II | Active |
| Carbon Fiber Accessory Kit | 6-020-10-5 | FDA UDI | Class I | Active |
| Skytron | 4A-PF66 Freedom | FDA UDI | Class I | Active |
| Skytron P base box | H8-200-14 | FDA UDI | Class I | Active |
| Sterling Washers | P1500-WC | FDA UDI | Class II | Active |
| Lube-Zyme | J5-010-12 | FDA UDI | Class II | Active |
| Sterling C2000 | C2000W-E208 | FDA UDI | Class II | Active |
| Skytron Moderate Alkaline Detergent | SKY-110SCLF-5 | FDA UDI | Class II | Active |
| Skytron warming cabinet | W1-652421 | FDA UDI | Class II | Active |
| Skytron | 4-030-42-2WS | FDA UDI | Class I | Active |
| Skytron Acidic Neutralizer | SKY-200-30 | FDA UDI | Class II | Active |
| Skytron SCLF Multi-Enzymatic Cleaner | SKY-404SCLF-55 | FDA UDI | Class II | Active |
| "L" type anesthesia screen | 6-020-04-1 | FDA UDI | Class I | Active |
| I-Series Washers | I5-S | FDA UDI | Class II | Active |
| CleanStart | CSTART-9601 | FDA UDI | Class II | Active |
| Skytron | 1-011-02-22R | FDA UDI | Class I | Active |
| Integrity Sterilizers | INTEGRITY 270VP | FDA UDI | Class II | Active |
| Skytron | 4A-ERCS-15 Freedom | FDA UDI | Class I | Active |
| Skytron | F130 SERIES Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-23-B | FDA UDI | Class I | Active |
| Skytron | 2-010-02-3S | FDA UDI | Class I | Active |
| Raised Armboard without Clamp | 2-020-01-1 | FDA UDI | Class I | Active |
| Skytron Scope-Zyme Multi Enzymatic Cleaner | SKY-405SCLF-55 | FDA UDI | Class II | Active |
| Skytron | 1-011-11-32 | FDA UDI | Class I | Active |
| Skytron | 5-010-09-2BC | FDA UDI | Class I | Active |
| Skytron | F310 SERIES Freedom | FDA UDI | Class I | Active |
| Hercules | 6702 | FDA UDI | Class I | Active |
| Skytron | 4A-PF72 Freedom | FDA UDI | Class I | Active |
| Skytron | 4A-FHA Freedom | FDA UDI | Class I | Active |
| Skytron wingbar E3 | H8-300-04-A | FDA UDI | Class I | Active |
| Skytron 22" Shelf with stainless steel top E3 | 3PMSHSS | FDA UDI | Class I | Active |
| Skytron | 4A-ERW-C Freedom | FDA UDI | Class I | Active |
| Skytron | 4-030-44-2WS | 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. |