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MONTERIS MEDICAL CORP

Last updated September 17, 2026

Information

Country: US
Address: 131 Cheshire Lane, Suite 100, Minnetonka, MN, 55305
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3009970070
DUNS Number: —

Catalogue (182)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
NeuroBlate Optic FullFire® Laser Probe	20893-5	FDA UDI	Class II	Active
AtamA System	20648	FDA UDI	Class II	Active
Mini-Bolt System	21155	FDA UDI	Class I	Active
AtamA™ System	20400	FDA UDI	Class II	Active
AtamA™ System	20764	FDA UDI	Class II	Active
NeuroBlate Optic SideFire® Laser Probe	20891-00	FDA UDI	Class II	Active
NeuroBlate Optic SideFire® Laser Probe	20891-000	FDA UDI	Class II	Active
AtamA™ System	20468	FDA UDI	Class II	Active
FullFire® Diffusing Tip Laser Probe	20414-3	FDA UDI	Class II	Unknown
Mini-Bolt System	20754	FDA UDI	Class I	Active
Mini-Bolt System	21247	FDA UDI	Class I	Active
AtamA™ System	20566	FDA UDI	Class II	Active
3.3mm Mini-Bolt VUE	21133	FDA UDI	Class I	Active
Mini-Bolt System	20811	FDA UDI	Class I	Active
3.3mm Mini-Bolt	21099	FDA UDI	Class I	Active
NeuroBlate Optic FullFire® Laser Probe	20895-3	FDA UDI	Class II	Active
FullFire® Diffusing Tip Laser Probe	20414-1	FDA UDI	Class II	Unknown
NeuroBlate Optic FullFire® Laser Probe	20893-4	FDA UDI	Class II	Active
Mini-Bolt System	21065	FDA UDI	Class I	Active
FullFire® Select Diffusing Tip Laser Probe	20624-00	FDA UDI	Class II	Unknown
Mini-Bolt System	20637	FDA UDI	Class I	Active
NeuroBlate Optic FullFire® Laser Probe	20893-00	FDA UDI	Class II	Active
SideFire® Directional Laser Probe	20368-000	FDA UDI	Class II	Unknown
Mini-Bolt System	20802	FDA UDI	Class I	Active
FullFire® Diffusing Tip Laser Probe	20414-5	FDA UDI	Class II	Unknown
SideFire® Directional Laser Probe	20368-000	FDA UDI	Class II	Unknown
FullFire® Select Diffusing Tip Laser Probe	20624-4	FDA UDI	Class II	Unknown
NeuroBlate® System	20980	FDA UDI	Class II	Active
FullFire® Select Diffusing Tip Laser Probe	20624-000	FDA UDI	Class II	Unknown
Mini-Bolt System	20784	FDA UDI	Class I	Active
SideFire® Directional Laser Probe	20368-00	FDA UDI	Class II	Unknown
FullFire® Select Diffusing Tip Laser Probe	20624-000	FDA UDI	Class II	Unknown
FullFire® Diffusing Tip Laser Probe	20414-4	FDA UDI	Class II	Unknown
Mini-Bolt System	20819	FDA UDI	Class I	Active
Mini-Bolt System	20821	FDA UDI	Class I	Active
FullFire® Diffusing Tip Laser Probe	20414-4	FDA UDI	Class II	Unknown
SideFire® Directional Laser Probe	20368-4	FDA UDI	Class II	Unknown
FullFire® Select Diffusing Tip Laser Probe	20624-4	FDA UDI	Class II	Unknown
NeuroBlate® System	20720	FDA UDI	Class II	Unknown
SideFire® Directional Laser Probe	20368-3	FDA UDI	Class II	Unknown
NeuroBlate® System	20360	FDA UDI	Class II	Unknown
AtamA™ System	20439	FDA UDI	Class II	Active
NeuroBlate® System	20360	FDA UDI	Class II	Unknown
FullFire® Diffusing Tip Laser Probe	20414-1	FDA UDI	Class II	Unknown
SideFire® Directional Laser Probe	20368-2	FDA UDI	Class II	Unknown
FullFire® Select Diffusing Tip Laser Probe	20624-5	FDA UDI	Class II	Unknown
SideFire® Directional Laser Probe	20368-5	FDA UDI	Class II	Unknown
SideFire® Directional Laser Probe	20368-5	FDA UDI	Class II	Unknown
NeuroBlate Optic FullFire® Laser Probe	20895-5	FDA UDI	Class II	Active
AXiiiS Stereotactic Miniframe	20503	FDA UDI	Class II	Unknown

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FDA Recalls (4)

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
Oct 5, 2017	Z-0194-2018	—	terminated	The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
Mar 25, 2016	Z-1614-2016	—	terminated	Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
Oct 3, 2014	Z-0228-2015	—	terminated	Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Oct 3, 2014	Z-0227-2015	—	terminated	Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.