510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
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233
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168
Obstetrics & Gynecology
61
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49
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1295
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18
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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
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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Lineus Medical
Medical Device Manufacturer
·
US , Fayetteville , AZ
Lineus Medical - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Lineus Medical
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 29, 2023
SafeBreak® Vascular
K231957
·
QOI
General Hospital
·
88d
Cleared
May 19, 2023
SafeBreak® Vascular
K223486
·
QOI
General Hospital
·
179d
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2
General Hospital
2