510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1663
Chemistry
362
Dental
1334
Ear, Nose, Throat
244
Gastroenterology & Urology
963
General & Plastic Surgery
2184
General Hospital
2043
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
466
Neurology
963
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2875
Pathology
52
Physical Medicine
515
Radiology
2430
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Software Nemotec S.L.
Medical Device Manufacturer
·
ES , Arroyomolinos, Madrid
Software Nemotec S.L. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2019
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Software Nemotec S.L.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Nov 21, 2023
NemoCast
K232549
·
PNN
Dental
·
90d
Cleared
Jun 05, 2020
NemoCast
K193003
·
PNN
Dental
·
221d
Cleared
Apr 23, 2020
NemoFAB
K192475
·
LLZ
Dental
·
226d
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5
Dental
3
Radiology
2