Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Monteris Medical with 22 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated Sep 3, 2026: NeuroBlate System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 3, 2026 | NeuroBlate SystemK262315 · ONO | 510(k) clearances |
| Apr 23, 2026 | NeuroBlate SystemK260976 · ONO | 510(k) clearances |
| Jun 4, 2024 | Monteris Medical NeuroBlate SystemK240877 · ONO | 510(k) clearances |
| Dec 8, 2023 | NeuroBlate SystemK231061 · GEX | 510(k) clearances |
| Mar 15, 2023 | NeuroBlate Fusion-S Software V3.17K222983 · GEX | 510(k) clearances |
| Aug 21, 2020 | NeuroBlate SystemK201056 · GEX | 510(k) clearances |
| Jan 3, 2020 | NeuroBlate SystemK193375 · GEX | 510(k) clearances |
| Oct 15, 2018 | NeuroBlate SystemK182036 · GEX | 510(k) clearances |
| Oct 5, 2017 | MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.Class I · The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) | Device recalls |
| Mar 25, 2016 | NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01Class I · Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting int | Device recalls |
| Oct 3, 2014 | FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlClass II · Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. | Device recalls |
| Oct 3, 2014 | SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlatClass II · Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
