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 19 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spectra Examination Light Series | AUT1S | FDA UDI | Class I | Active |
| Skytron Scope-Zyme Multi Enzymatic Cleaner | SKY-405SCLF-30 | FDA UDI | Class II | Active |
| Skytron | 1-011-03-2 | FDA UDI | Class I | Active |
| CleanStart | CSTART-9201 | FDA UDI | Class II | Active |
| Skytron | 5-010-29-D | FDA UDI | Class I | Active |
| Skytron | 5-010-09-2BL | FDA UDI | Class I | Active |
| Skytron | 4-031-01 | FDA UDI | Class I | Active |
| Skytron Medi-Sheen | SKY-800-5 | FDA UDI | Class II | Active |
| Premium Armboard | 2-010-08 | FDA UDI | Class I | Active |
| Skytron Cart Wash Detergent | SKY-500-30 | FDA UDI | Class II | Active |
| I-Series Washers | I5-RIB | FDA UDI | Class II | Active |
| Skytron | 4A-KCVB Freedom | FDA UDI | Class I | Active |
| Sterling P1000 Washer Disintector | P1000-S480E | FDA UDI | Class II | Active |
| Skytron | 1-011-07-3 | FDA UDI | Class I | Active |
| Skytron | 1-011-05-3 | FDA UDI | Class I | Active |
| Skytron | 4A-PUS-22 Freedom | FDA UDI | Class I | Active |
| Skytron | GS70-2 | FDA UDI | Class I | Active |
| Skytron 16.5" pullout KB tray | H8-300-32 | FDA UDI | Class I | Active |
| Skytron | 5-010-15-B | FDA UDI | Class I | Unknown |
| Skytron DoVera | DM520 | FDA UDI | Class II | Active |
| Skytron | 1-011-06-32 | FDA UDI | Class I | Active |
| Sterling P1800 | 2918247 | FDA UDI | Class II | Active |
| Skytron | 4-030-61-S | FDA UDI | Class I | Active |
| Skytron | 1-011-04-3 | FDA UDI | Class I | Active |
| Skytron | 4A-PD-CRD Freedom | FDA UDI | Class I | Active |
| Skytron drawer lock set all diff | H8-300-25-1 | FDA UDI | Class I | Active |
| Skytron | 4A-VESA-PMO Freedom | FDA UDI | Class I | Active |
| Skytron Neutral pH Detergent Low Foam | SKY-400-1 | FDA UDI | Class II | Active |
| Lithotomy Stirrups | 4-020-02 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-CON-RWH-208 | FDA UDI | Class II | Active |
| Skytron | 2-010-02-2S | FDA UDI | Class I | Active |
| Skytron | 6-020-10-6 | FDA UDI | Class I | Active |
| Skytron | 5-010-06-3B | FDA UDI | Class I | Unknown |
| CleanStart | CSTART-7105 | FDA UDI | Class II | Active |
| Sterling P1800 | 2918345 | FDA UDI | Class II | Active |
| I-Series Washers | I5-PT | FDA UDI | Class II | Active |
| I-Series Washers | I5-2LR | FDA UDI | Class II | Active |
| Skytron | F20H SERIES Freedom | FDA UDI | Class I | Active |
| Skytron | 5-010-14-4 | FDA UDI | Class I | Active |
| Auxiliary base connector kit | D5-035-14 | FDA UDI | Class I | Active |
| Standard Bar Clamp | 6-040-10 | FDA UDI | Class I | Active |
| CleanStart | CSTART-7725 | FDA UDI | Class II | Active |
| X-Ray Foot/Leg Section | 5-010-02-4B | FDA UDI | Class I | Unknown |
| Sterling C2000 | C2000LW-S208 | FDA UDI | Class II | Active |
| Skytron | 4A-CS-37 Freedom | FDA UDI | Class I | Active |
| Skytron | 4-030-22-3S | FDA UDI | Class I | Active |
| Singer Starr Leg Stacker | 4-030-66 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-3 | FDA UDI | Class I | Active |
| Skytron SCLF Neutral pH Detergent LF 2x Conc. | SKY-400SCLF-55 | FDA UDI | Class II | Active |
| Skytron Sterling Lubricant | SKY-300SCLF-55 | FDA UDI | Class II | 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. |