510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1660
Chemistry
362
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2177
General Hospital
2039
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
960
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2846
Pathology
52
Physical Medicine
515
Radiology
2417
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Monteris Medical,
Medical Device Manufacturer
·
US , Alameda , CA
Monteris Medical, - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 2009
Official Website
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Monteris Medical,
General & Plastic Surgery
✕
4
devices
1-4 of 4
Filters
Cleared
Nov 17, 2017
NeuroBlate System
K173305
·
GEX
General & Plastic Surgery
·
30d
Cleared
Oct 20, 2017
NeuroBlate System
K172881
·
GEX
General & Plastic Surgery
·
29d
Cleared
Apr 07, 2017
NeuroBlate System
K170724
·
GEX
General & Plastic Surgery
·
29d
Cleared
May 01, 2009
MONTERIS MEDICAL AUTOLITT LASER PROBE
K081509
·
GEX
General & Plastic Surgery
·
337d
Filters
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12
Neurology
7
General & Plastic Surgery
4
Radiology
1