510k
Database
Specialties
Anesthesiology
133
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
516
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
167
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1293
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Hubly, Inc.
Medical Device Manufacturer
·
US , Lisle , IL
Hubly, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Hubly, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 06, 2025
Hubly Drill (H100)
K250815
·
HBE
Neurology
·
234d
Cleared
May 04, 2023
Hubly Electric Drill (H100)
K230619
·
HBE
Neurology
·
59d
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2
Neurology
2