510k
Database
Specialties
Anesthesiology
134
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569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
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67
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56
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0
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233
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168
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61
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49
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1295
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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
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
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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Dev4
Medical Device Manufacturer
·
US , Houston , TX
Dev4 - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Dev4
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 10, 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312
·
HWC
Orthopedic
·
78d
Cleared
Jun 13, 2025
Eleganz Fusion Screw System (Fusion Screw System)
K250251
·
HWC
Orthopedic
·
136d
Filters
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Orthopedic
2