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NuMED, Inc.

United States·US-MF-000010948

Last updated September 17, 2026

Information

Page 11 of 11

Device	Model / Reference	Registries	Class	Status
Tyshak	PDC164	EUDAMED	Class III	Active
Tyshak	PDC140	EUDAMEDFDA 510(k)	Class III	Active
Mounted CP Stent	MCP048	EUDAMED	Class III	Active
Z-Med Ii	PDZ662	EUDAMEDFDA 510(k)	Class III	Active
Z-Med-X	PDZ412	EUDAMED	Class III	Active
Z-Med	PDZ367	EUDAMEDFDA 510(k)	Class III	Active
Tyshak II	PDC524	EUDAMED	Class III	Active
Tyshak NuCLEUS	TN034	EUDAMED	Class III	Active
Mounted CP Stent	MCP062	EUDAMED	Class III	Active
Z-Med	PDZ394	EUDAMED	Class III	Active
COEfficient	COE139	EUDAMEDFDA 510(k)	Class III	Active

Not available yet.

Not available yet.

Not available yet.

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
Apr 21, 2025	Z-1754-2025	—	terminated	Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
Oct 17, 2018	Z-0510-2019	—	terminated	Instructions for Use booklets were not included on the outer pouch
Oct 17, 2018	Z-0511-2019	—	terminated	Instructions for Use booklets were not included on the outer pouch
Sep 23, 2009	Z-0509-2010	—	terminated	The firm received a complaint from the sole direct account that while performing an inventory review it was observed that the packaging of the IMPACT catheter was cracked and deteriorating. The product was still in its packaging and never used. The customer referred to it as looking like "paint crackle." The risk is that for continued sterility to be assured, the packaging must remain intact.
Jun 26, 2003	Z-0983-03	—	terminated	Lacks a PMA or 510k.