Medical Device Manufacturer · US , Alameda , CA

Monteris Medical,

11 submissions · 11 cleared · Since 2009
11
Total
11
Cleared
0
Denied

Monteris Medical, — FDA 510(k) Submissions

Monteris Medical, has submitted 11 FDA 510(k) premarket notifications since 2009, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Neurological Stereotaxic Instrument, Coil, Magnetic Resonance, Specialty, Neurosurgical Laser With Mr Thermography . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Monteris Medical NeuroBlate System
K240877 · ONO Neurosurgical Laser With... · Neurology
Jun 2024 67d
NeuroBlate System
K231061 · GEX Powered Laser Surgical... · Neurology
Dec 2023 239d
NeuroBlate Fusion-S Software V3.17
K222983 · GEX Powered Laser Surgical... · Neurology
Mar 2023 168d
NeuroBlate System
K193375 · GEX Powered Laser Surgical... · Neurology
Jan 2020 29d
NeuroBlate System
K182036 · GEX Powered Laser Surgical... · Neurology
Oct 2018 77d
NeuroBlate System
K173305 · GEX Powered Laser Surgical... · General & Plastic Surgery
Nov 2017 30d
NeuroBlate System
K172881 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 2017 29d
NeuroBlate System
K170724 · GEX Powered Laser Surgical... · General & Plastic Surgery
Apr 2017 29d
ATAMA SYSTEM
K132444 · MOS Coil, Magnetic Resonance,... · Radiology
Jan 2014 174d
MONTERIS MEDICAL UFO
K090240 · HAW Neurological Stereotaxic... · Neurology
Aug 2009 185d
MONTERIS MEDICAL AUTOLITT LASER PROBE
K081509 · GEX Powered Laser Surgical... · General & Plastic Surgery
May 2009 337d
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