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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 7 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ergon Boom Series | Ergon 3 | FDA UDI | Class I | Active |
| Foot rests** (pr.) | 4-030-01 | FDA UDI | Class I | Active |
| X-Ray Top Set | 5-010-10-B | FDA UDI | Class I | Unknown |
| Skytron Acidic Neutralizer | SKY-200SCLF-1 | FDA UDI | Class II | Active |
| Skytron | 4-030-44-5WS | FDA UDI | Class I | Active |
| Perineal Cutout Cover | 5-020-01 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-31 | FDA UDI | Class I | Active |
| Skytron | 1-011-10-21 | FDA UDI | Class I | Active |
| Tri Clamp | 6-040-03-E | FDA UDI | Class I | Active |
| Skytron | 5-010-27-3B | FDA UDI | Class I | Active |
| Skytron 22" plastic drawer | H8-300-20 | FDA UDI | Class I | Active |
| Center Focus Handle | B1-530-40-B | FDA UDI | Class II | Active |
| Stellar Surgical Light Series | Stellar XL | FDA UDI | Class II | Active |
| Sterling P1800 | P1800-D480S | FDA UDI | Class II | Active |
| Skytron 16.5" Shelf with handles E3 | 3KMSH-H | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-DVXISI | FDA UDI | Class II | Active |
| Skytron | 4A-SHC-17 Freedom | FDA UDI | Class I | Active |
| Sterling P1000 Washer Disintector | P1000-S208S | FDA UDI | Class II | Active |
| Skytron | 5-010-05-B | FDA UDI | Class I | Unknown |
| Skytron | 1-011-06-31 | FDA UDI | Class I | Active |
| Skytron | 7-010-08-4S | FDA UDI | Class I | Active |
| EZ-Roll Cart | 6-020-10 | FDA UDI | Class I | Active |
| Skytron | 5-010-09-2B | FDA UDI | Class I | Active |
| Uro drain tray | 4-040-05 | FDA UDI | Class I | Active |
| Skytron | 4-031-02-5WS | FDA UDI | Class I | Active |
| Sterling P1000 Washer Disintector | P1000-S208E | FDA UDI | Class II | Active |
| Integrity Sterilizers | INTEGRITY 215SG | FDA UDI | Class II | Active |
| TV-3 Handle Camera, Aurora II Series | B1-710-56 | FDA UDI | Class I | Active |
| Sterling C2000 | C2000-E480 | FDA UDI | Class II | Active |
| Skytron | 4A-PD-22-22 Freedom | FDA UDI | Class I | Active |
| Integrity Sterilizers | 270-CR | FDA UDI | Class II | Active |
| Skytron | 2-060-064P | FDA UDI | Class I | Active |
| CleanStart | CSTART-7101 | FDA UDI | Class II | Active |
| I-Series Washers | I5-PRSS | FDA UDI | Class II | Active |
| I-Series Washers | I5-TC | FDA UDI | Class II | Active |
| Skytron | 5-010-09-B | FDA UDI | Class I | Unknown |
| General purpose head support | 7-010-01 | FDA UDI | Class I | Active |
| Skytron | 1-011-15-5 | FDA UDI | Class I | Active |
| Skytron Narkomed GS tether | H9-200-08 | FDA UDI | Class I | Active |
| X-Ray Top Set | 5-010-09 | FDA UDI | Class I | Active |
| Skytron large VST clamp E3 | H8-300-39-A | FDA UDI | Class I | Active |
| Skytron Cart Rinse and Drying Agent | SKY-600-30 | FDA UDI | Class II | Active |
| Skytron | 4A-PUK-22 Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-11-53 | FDA UDI | Class I | Active |
| Integrity Sterilizers | 270-LC | FDA UDI | Class II | Active |
| Sterling M1000 | M1000-D208S | FDA UDI | Class II | Active |
| Integrity Sterilizers | INTEGRITY 215 | FDA UDI | Class II | Active |
| Skytron CO2 bottle holder Early | H8-200-08-1 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-21 | FDA UDI | Class I | Active |
| Skytron 40" back cover | H8-200-11 | 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. |