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Waters Medical Systems, LLC

Last updated September 17, 2026

About

Waters Medical Systems empowers transplant teams to improve transplant success and graft survival rates—enhancing patients’ lives.

From the manufacturer's own website. Source

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Device	Model / Reference	Registries	Class	Status
Cannula 9mm SS, Non-Sterile	9mm SS	FDA UDI	Class II	Active
CANNULA 6MM TEFLON STERILE - 1/packaging	CANNULA 6MM TEFLON STERILE	FDA UDI	Class II	Active
CANNULA 9MM TEFLON STERILE - 1/packaging	CANNULA 9MM TEFLON STERILE	FDA UDI	Class II	Active
Oxicom 3000 Box Kit	Oxicom 3000 Kit	FDA UDI	Class II	Unknown
CANNULA 15MM TEFLON STERILE - 1/packaging	CANNULA 15MM TEFLON STERILE	FDA UDI	Class II	Active
CANNULA 7MM TEFLON STERILE - 1/packaging	CANNULA 7MM TEFLON STERILE	FDA UDI	Class II	Active
Insulated Cassette Cover Dcm	INSULATED CASSETTE COVER DCM	FDA UDI	Class II	Active
MOX/RM3 Battery	MOX/RM3 Battery	FDA UDI	Class II	Active
Perf-Gen Pulsatile Perfusion Solution	K121736	FDA 510(k)	Class II	Active
Waves	K111521	FDA 510(k)	Class II	Active
Bel-Gen Cold Storage Solution	K121618	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
Mar 21, 2022	Z-1013-2022	—	terminated	There is a potential for the WCM cassette pump head leaking solution.