510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
275
Orthopedic
2923
Pathology
52
Physical Medicine
515
Radiology
2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Exo, Inc.
Medical Device Manufacturer
·
US , Walker , MI
Exo, Inc. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 1983
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Exo, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 24, 2025
Lung AI (LAI001)
K243239
·
MYN
Radiology
·
196d
Cleared
Nov 20, 2024
Strain AI (SAI001)
K242359
·
QIH
Radiology
·
103d
Cleared
Nov 17, 2023
AI Platform (AIP001)
K232501
·
QIH
Radiology
·
92d
Cleared
Jun 22, 2023
Bladder AI (AIBV01)
K230497
·
QIH
Radiology
·
118d
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5
Radiology
4
Gastroenterology & Urology
1