510k
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134
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569
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164
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314
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68
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289
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519
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373
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67
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56
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233
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167
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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
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IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
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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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Abbott Ireland
Medical Device Manufacturer
·
IE , Lisnamuck
Abbott Ireland - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Abbott Ireland
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 24, 2025
Glucose2
K252357
·
CFR
Chemistry
·
87d
Cleared
Feb 10, 2025
Calcium2
K244042
·
CJY
Chemistry
·
42d
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2
Chemistry
2