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 3 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sterling Washers | P1500-208S | FDA UDI | Class II | Active |
| Ergon Boom Series | Ergon 3 | FDA UDI | Class I | Active |
| X-Ray Top Seat Section | 5-010-15-3B | FDA UDI | Class I | Unknown |
| Skytron | 1-011-06-2R | FDA UDI | Class I | Active |
| Skytron | 1-011-05-23 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-43 | FDA UDI | Class I | Active |
| Skytron | 4A-PD-KEY-N-V Freedom | FDA UDI | Class I | Active |
| Skytron | 4-030-44-4WS | FDA UDI | Class I | Active |
| Skytron Cart Rinse and Drying Agent | SKY-600-15 | FDA UDI | Class II | Active |
| Skytron Neutral pH Detergent Low Foam | SKY-400-30 | FDA UDI | Class II | Active |
| Skytron | 1-011-06-22 | FDA UDI | Class I | Active |
| Skytron | 1-011-11-22 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-23 | FDA UDI | Class I | Active |
| Skytron Basket E3 | H8-200-09-A | FDA UDI | Class I | Active |
| Neuro Adapter | 7-010-02-B1 | FDA UDI | Class I | Active |
| Skytron | 5-010-10-3 | FDA UDI | Class I | Active |
| I-Series Washers | I3-CP | FDA UDI | Class II | Active |
| Skytron | 4-030-01-2S | FDA UDI | Class I | Active |
| Skytron | 4A-SHC-32 Freedom | FDA UDI | Class I | Active |
| Skytron Neutral pH Detergent Low Foam | SKY-400-5 | FDA UDI | Class II | Active |
| Sterling P/M1000 Flexible Rack | 1000-FIX6 | FDA UDI | Class II | Active |
| Sterling P/M1000 MIC Rack | 1000-MIC-WON | FDA UDI | Class II | Active |
| Skytron | 4-030-43-5WS | FDA UDI | Class I | Active |
| Skytron | 4-030-40-2S | FDA UDI | Class I | Active |
| Skytron | 2-010-07-2WS | FDA UDI | Class I | Active |
| Skytron | 4A-ERSH-22 Freedom | FDA UDI | Class I | Active |
| Skytron | 7-010-08-5S | FDA UDI | Class I | Active |
| Skytron | 4A-KCUB Freedom | FDA UDI | Class I | Active |
| Skytron warming cabinet | W1-752421 | FDA UDI | Class II | Active |
| Skytron | 4KC-49 Freedom | FDA UDI | Class I | Active |
| Sterling Washers | P1500-LOAD1 | FDA UDI | Class II | Active |
| Integrity Sterilizers | INTEGRITY 270 | FDA UDI | Class II | Active |
| Sterling C2000 | 2006662 | FDA UDI | Class II | Active |
| Seat Section X-Ray Top | 5-010-05-3B | FDA UDI | Class I | Unknown |
| Skytron | 4A-PD-22-EX Freedom | FDA UDI | Class I | Active |
| Sterling P/M1000 Conductivity sensor | 1000-SNSR | FDA UDI | Class II | Active |
| Ergon Boom Series | Ergon 3 | FDA UDI | Class I | Active |
| Sterling P/M1000 Basket | 1000-FLX-KB | FDA UDI | Class II | Active |
| Ergon Boom Series | Ergon 2 | FDA UDI | Class II | Active |
| Skytron Streamline system with narrow wing | ISS-NW | FDA UDI | Class I | Active |
| Skytron | 1-011-08-3-BOS | FDA UDI | Class I | Active |
| Skytron | 4A-CA-SH Freedom | FDA UDI | Class I | Active |
| Skytron 16.5" drawer | H8-300-18 | FDA UDI | Class I | Active |
| Sterling Washer | P1500-UNLD1 | FDA UDI | Class II | Active |
| X-Ray Seat Section | 5-010-09-3 | FDA UDI | Class I | Active |
| Skytron | 3-060-01-4S | FDA UDI | Class I | Active |
| X-Ray Foot/Leg Section | 5-010-09-4B | FDA UDI | Class I | Unknown |
| Skytron | 4-030-61-3S | FDA UDI | Class I | Active |
| Skytron | 5-010-31-B | FDA UDI | Class I | Active |
| Skytron Streamline Critical Care 2040 bed mount | SYK-CC | FDA UDI | Class I | 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. |