510k
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544
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1689
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1347
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250
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979
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2204
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2052
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126
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100
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8
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472
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437
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280
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2977
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52
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515
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2463
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
396
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358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
283
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Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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A-1 Engineering
Medical Device Manufacturer
·
US , Irvine , CA
A-1 Engineering - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - A-1 Engineering
Physical Medicine
✕
1
devices
1-1 of 1
Filters
Cleared
Feb 26, 2019
Body System
K182440
·
NGX
Physical Medicine
·
172d
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2
Physical Medicine
1
Neurology
1