510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1694
Chemistry
370
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2213
General Hospital
2057
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
438
Ophthalmic
280
Orthopedic
2986
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52
Physical Medicine
515
Radiology
2466
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
413
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
284
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Molekule, Inc.
Medical Device Manufacturer
·
US , San Francisco , CA
Molekule, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Molekule, Inc.
General Hospital
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 20, 2021
Molekule Air Pro
K211194
·
FRA
General Hospital
·
121d
Cleared
Feb 23, 2021
Molekule Air Mini, Molekule Air Mini +
K202339
·
FRA
General Hospital
·
190d
Cleared
Apr 15, 2020
Molekule Air Pro RX
K200500
·
FRA
General Hospital
·
47d
Filters
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3
General Hospital
3