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Skytron, LLC

Last updated September 17, 2026

Information

Country: US
Address: 5085 Corporate Exchange Blvd SE, Grand Rapids, MI, 49512
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1825014
DUNS Number: —

Catalogue (1084)

Page 22 of 22

Device	Model / Reference	Registries	Class	Status
Skytron 32" shelf	XMSH	FDA UDI	Class I	Active
Flex - da Vinci Si Tooling Connector Assembly Kit	CS-1001-000	FDA UDI	Class II	Active
Skytron	4A-ERCS-20 Freedom	FDA UDI	Class I	Active
Restraint strap	6-010-52-1	FDA UDI	Class I	Active
Skytron	5-010-28-B	FDA UDI	Class I	Active
Skytron	2-060-01-5WS	FDA UDI	Class I	Active
Skytron	GS70	FDA UDI	Class I	Active
Skytron	1-011-11-33	FDA UDI	Class I	Active
Skytron	4A-HSKV-17 Freedom	FDA UDI	Class I	Active
Skytron warming cabinet	W1-652427	FDA UDI	Class II	Active
Skytron	4-031-01-5WS	FDA UDI	Class I	Active
Sterling C2000	C2000L-S480	FDA UDI	Class II	Active
DoVera DE12 Examination Light Series	DE12C	FDA UDI	Class I	Active
Side Rail Extension	6-070-03	FDA UDI	Class I	Active
Argos II/AR24 Examination Lights	AR24	FDA UDI	Class I	Active
Snap Restraint Strap	6-010-42	FDA UDI	Class I	Active
Skytron warming cabinet	W1-753027	FDA UDI	Class II	Active
Schure Socket XL	6-040-11	FDA UDI	Class I	Active
Skytron	5-010-31-4B	FDA UDI	Class I	Active
Sterling P1800	1800-FIX5	FDA UDI	Class II	Active
Skytron	4A-PF60 Freedom	FDA UDI	Class I	Active
CleanStart	CSTART-9400	FDA UDI	Class II	Active
Skytron	4A-PD-17-EX Freedom	FDA UDI	Class I	Active
Skytron	5-010-09-3B	FDA UDI	Class I	Unknown
Skytron Cart Wash Detergent	SKY-500-15	FDA UDI	Class II	Active
Skytron 22" pullout KB tray w/o mouse E3	H8-300-26-A	FDA UDI	Class I	Active
Sterling P1000 Washer Disintector	P1000-S480S	FDA UDI	Class II	Active
Basket Accessory Cart	6-020-10-4	FDA UDI	Class I	Active
Skytron	1-011-06-34	FDA UDI	Class I	Active
Sterling Washers	P1500-FIX6L	FDA UDI	Class II	Active
Skytron	5-010-14-4B	FDA UDI	Class I	Unknown
Skytron	1-011-13-2	FDA UDI	Class I	Active
Skytron	4-030-13-3SOF	FDA UDI	Class I	Active
Ergon Boom Series	Ergon 3	FDA UDI	Class II	Active

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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.