510k
Database
Specialties
Anesthesiology
134
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569
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164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
519
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373
Hematology
67
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56
Medical Genetics
0
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233
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167
Obstetrics & Gynecology
61
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49
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1293
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18
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86
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870
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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
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Unity Medical, Inc.
Medical Device Manufacturer
·
US , Edina , MN
Unity Medical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Unity Medical, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 24, 2025
VersaD Delivery Catheter
K251372
·
QJP
Neurology
·
175d
Cleared
Jan 17, 2025
VersaD Delivery Catheter
K242051
·
QJP
Neurology
·
189d
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Neurology
2