510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1709
Chemistry
380
Dental
1353
Ear, Nose, Throat
252
Gastroenterology & Urology
981
General & Plastic Surgery
2215
General Hospital
2073
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
441
Ophthalmic
282
Orthopedic
3017
Pathology
52
Physical Medicine
515
Radiology
2477
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
290
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
235
MAX
Intervertebral Fusion Device...
229
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Mecta Corporation
Medical Device Manufacturer
·
US , Suite B , OR
Mecta Corporation - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Mecta Corporation
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 04, 2021
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
K201309
·
JXL
Neurology
·
385d
Cleared
Apr 26, 2020
MECTA Sigma
K192834
·
QGH
Neurology
·
207d
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2
Neurology
2