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 12 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Skytron | 1-011-06-24 | FDA UDI | Class I | Active |
| Sterling P1800 | 2918698 | FDA UDI | Class II | Active |
| Prone positioning frame | 3-070-01 | FDA UDI | Class I | Active |
| Flex - Suction Tool Instrument Connector | CS-1000-000 | FDA UDI | Class II | Active |
| Spectra Examination Light Series | AUT1C | FDA UDI | Class I | Active |
| Skytron display spacer | SIEMENS-ADAPTER | FDA UDI | Class I | Active |
| Skytron 32" Shelf with stainless steel top E3 | 3XMSHSS | FDA UDI | Class I | Active |
| Skytron | 1-011-13-5 | FDA UDI | Class I | Active |
| Skytron | 4A-CB-32 Freedom | FDA UDI | Class I | Active |
| Adapter Uro Tray Hose | 4-040-14-11 | FDA UDI | Class I | Active |
| Skytron | 1-011-05-5 | FDA UDI | Class I | Active |
| Skytron | 1-011-06-23 | FDA UDI | Class I | Active |
| Skytron Streamline Boom Adapter | ISS-BOOM | FDA UDI | Class I | Active |
| Skytron | 1-011-06-41 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-MIC-WN | FDA UDI | Class II | Active |
| Skytron 22" Shelf E3 | 3PMSH | FDA UDI | Class I | Active |
| Seat Section | 5-010-16-3B | FDA UDI | Class I | Unknown |
| CleanStart | CSTART-8525 | FDA UDI | Class II | Active |
| I-Series Washers | I5-RIKB | FDA UDI | Class II | Active |
| Sterling Washers | P1500-FLX5 | FDA UDI | Class II | Active |
| Skytron | 2-010-05-3S | FDA UDI | Class I | Active |
| Skytron | 1-011-08-51 | FDA UDI | Class I | Active |
| Skytron | 1-011-02-22 | FDA UDI | Class I | Active |
| Standard Singer Starr Stacker | 2-060-06-PM | FDA UDI | Class I | Active |
| Skytron | 4A-LC-HM Freedom | FDA UDI | Class I | Active |
| Knee Crutches With Foot Support No Clamps | 4-010-03-1 | FDA UDI | Class I | Active |
| Skytron | 4VSTH-CP1 Freedom | FDA UDI | Class I | Active |
| Split Leg Section | 4-030-61 | FDA UDI | Class I | Active |
| Skytron | Freedom | FDA UDI | Class I | Active |
| Skytron | 1-011-06-44 | FDA UDI | Class I | Active |
| Sterling P1800 | 1800-HSM-208 | FDA UDI | Class II | Active |
| F102 Series Mount With 2 Lf Arms | F102 Series | FDA UDI | Class I | Active |
| Skytron | 5-010-10-4B | FDA UDI | Class I | Unknown |
| I-Series Washers | I3-MIS | FDA UDI | Class II | Active |
| Sterling P/M1000 MIC Module | 1000-MICM-FLX4 | FDA UDI | Class II | Active |
| Body Restraint | 6-010-53 | FDA UDI | Class I | Active |
| Skytron | 2-060-06-5P | FDA UDI | Class I | Active |
| Clarity | 3008 | FDA UDI | Class I | Active |
| CleanStart | CSTART-7705 | FDA UDI | Class II | Active |
| Skytron warming cabinet | W1-363021 | FDA UDI | Class II | Active |
| Skytron | 1-011-02-2B | FDA UDI | Class I | Active |
| Skytron | 1-011C-06-2 | FDA UDI | Class I | Active |
| Skytron | 4-031-02-3WS | FDA UDI | Class I | Active |
| Skytron Scope-Zyme Multi Enzymatic Cleaner | SKY-405SCLF-2.5 | FDA UDI | Class II | Active |
| Skytron warming cabinet | W1-653021 | FDA UDI | Class II | Active |
| Skytron | 2-010-02-4S | FDA UDI | Class I | Active |
| Sterling Washers | P1500-FLX-SH | FDA UDI | Class II | Active |
| Armboard for Singer Starr Stacker | 2-060-06 | FDA UDI | Class I | Active |
| Skytron Neutral pH Detergent Low Foam | SKY-400-55 | FDA UDI | Class II | Active |
| Skytron drawer lock set all same | H8-300-25-2 | 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. |