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EXSURCO MEDICAL, INC.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Mesh\|Ex	X101836	FDA UDI	Class I	Active
Mesh\|Ex	X101933	FDA UDI	Class I	Active
Amalgatome SD 4-inch Cutting Head	X100969	FDA UDI	Class I	Active
Mesh\|Ex	X101863	FDA UDI	Class I	Active
Amalgatome SD Hand Piece (Drive Unit)	X101016	FDA UDI	Class I	Active
Amalgatome SD 4-inch Lock Ring	X100825	FDA UDI	Class I	Active
Amalgatome SD 2-inch Cutting Head	X100968	FDA UDI	Class I	Active
Amalgatome SD System (2" & 4")	SDSYSTEM024	FDA UDI	Class I	Active
4-inch ASD Excision ring blade	X101788	FDA UDI	Class I	Active
2-inch ASD Excision ring blade	X101789	FDA UDI	Class I	Active
Mesh\|Ex	X101866	FDA UDI	Class I	Active
Mesh\|Ex	X101892	FDA UDI	Class I	Active
Amalgatome SD Sterilization Tray	X101005	FDA UDI	Class I	Active
Amalgatome SD 2-inch Lock Ring	X100768	FDA UDI	Class I	Active
Mesh\|Ex	X101882	FDA UDI	Class I	Active
Mesh\|Ex	X101876	FDA UDI	Class I	Active
Amalgatome SD Pneumatic Hose	X101004	FDA UDI	Class I	Active
Mesh\|Ex	X101855	FDA UDI	Class I	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
Apr 17, 2018	Z-2291-2018	—	terminated	Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.