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Neomedix Corp.

Last updated May 23, 2026

Information

Device	Model / Reference	Registries	Class	Status
Trabectome High Frequency Generator (100-240V)	550050	FDA UDI	Class II	Active
Trabectome I/A Console (100-240V)	550014-02	FDA UDI	Class II	Active
Trabectome High Frequency Generator (110V)	550047	FDA UDI	Class II	Active
Goniotome +I/A Handpiece	550052-11	FDA UDI	Class I	Active
Trabectome I/A Cannula	550037-01	FDA UDI	Class I	Active
Trabectome Handpiece	550035	FDA UDI	Class II	Active
Trabectome Fluidics Set	550034-01	FDA UDI	Class I	Active
Goniotome Handpiece	550052-15	FDA UDI	Class I	Active
Trabectome I/A Console (110V)	550014	FDA UDI	Class II	Active
Trabectome High Frequency Generator/Lp	K061258	FDA 510(k)	Class II	Active
Nmx-1000	K040584	FDA 510(k)	Class II	Active
Supraflow Console	K040239	FDA 510(k)	Class II	Active
Microsurgical Bipolar Handpiece	K024304	FDA 510(k)	Class II	Active

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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
May 28, 2007	Z-0071-2008	—	terminated	Failure of irrigation flow: The pinch valve in a few pumps may not consistently open to allow irrigation flow. In over 450 surgeries, the firm confirmed one instance of a valve that did not open. The electrically activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation flow to the eye during Trabectome surgery.