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 21 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sterling M1000 | M1000-D480S | FDA UDI | Class II | Active |
| Sterling C2000 | C2000LW-E480 | FDA UDI | Class II | Active |
| Skytron | 2-060-06-3P | FDA UDI | Class I | Active |
| CleanStart | CSTART-8105 | FDA UDI | Class II | Active |
| Skytron warming cabinet | W2-653021 | FDA UDI | Class II | Active |
| Skytron | 4-040-09-1S | FDA UDI | Class I | Active |
| Skytron | 4A-FPH-17 Freedom | FDA UDI | Class I | Active |
| Skytron | 3-040-12-3WS | FDA UDI | Class I | Active |
| Skytron Wingbar for racks | H8-200-04 | FDA UDI | Class I | Active |
| Skytron | 1-011-08-41 | FDA UDI | Class I | Active |
| Sterling P1800 | 2918803 | FDA UDI | Class II | Active |
| Skytron | 4-031-03-3WS | FDA UDI | Class I | Active |
| 5 Piece Split Leg Accessory Cart | 6-020-10-3 | FDA UDI | Class I | Active |
| Flex - Standard Luer Connector Kit | CS-1002-000 | FDA UDI | Class II | Active |
| Sterling P1800 | 1800-HSM-480 | FDA UDI | Class II | Active |
| Straps for 4-020-02-4 (pr.) | 4-020-02-2 | FDA UDI | Class I | Active |
| Sterling Washers | P1500-CNTR | FDA UDI | Class II | Active |
| Skytron | 7-010-03-2S | FDA UDI | Class I | Active |
| X-Ray Top Seat Section | 5-010-21-3NCB | FDA UDI | Class I | Active |
| Skytron | 1-011-16-5 | FDA UDI | Class I | Active |
| Instrument tray | 6-060-01 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-CON-RWH-480 | FDA UDI | Class II | Active |
| Skytron | 5-010-21-B | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-CNTR-MED | FDA UDI | Class II | Active |
| Skytron | 1-011-01-21 | FDA UDI | Class I | Active |
| Narrow head section | 7-010-07 | FDA UDI | Class I | Active |
| Skytron warming cabinet | W2-752427 | FDA UDI | Class II | Active |
| Skytron 48" back cover | H8-300-11 | FDA UDI | Class I | Active |
| Skytron | 4-090-17 | FDA UDI | Class I | Active |
| Sterling P/M1000 Da Vinci Si Stapler Holder | 1000-SIST | FDA UDI | Class II | Active |
| Skytron | 4-030-13-4S | FDA UDI | Class I | Active |
| Skytron | 1-011-06-3R | FDA UDI | Class I | Active |
| Skytron | 5-010-21-4B | FDA UDI | Class I | Active |
| Skytron | 1-011-06-32-LB | FDA UDI | Class I | Active |
| Skytron | 4A-ERW-W Freedom | FDA UDI | Class I | Active |
| CleanStart | CSTART-0701 | FDA UDI | Class II | Active |
| Skytron SCLF Neutral pH Detergent LF 2x Conc. | SKY-400SCLF-1 | FDA UDI | Class II | Active |
| Skytron Wingbar for VBA | H8-200-05 | FDA UDI | Class I | Active |
| Skytron | 4A-ERSH-17 Freedom | FDA UDI | Class I | Active |
| Skytron Acidic Neutralizer | SKY-200-55 | FDA UDI | Class II | Active |
| Sky-Lube | J5-010-14 | FDA UDI | Class II | Active |
| 18" Knee rest** | 4-030-10-B | FDA UDI | Class I | Active |
| Sterling P1800 | 9200003 | FDA UDI | Class II | Active |
| Camera Cover | B1-530-50 | FDA UDI | Class II | Active |
| Skytron Universal tether | H9-200-05 | FDA UDI | Class I | Active |
| Skytron | 4-030-22-2S | FDA UDI | Class I | Active |
| Skytron | 5-010-22-B | FDA UDI | Class I | Active |
| Skytron DoVera Positioning Handle | 1950287 | FDA UDI | Class II | Active |
| Sterling P1800 | 1800-MIC-WON | FDA UDI | Class II | Active |
| X-Ray Top Back Section Extended | 5-010-09-2BL | 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. |